Urinary event detection, tracking, and analysis

ABSTRACT

The present disclosure generally relates to methods and systems for generating a void profile for user void events. The method includes receiving by a processing element a plurality of outputs from a fluid level sensor corresponding to a plurality of levels of fluid flowing through a voiding device during a flow event; determining by the processing element a beginning and an end time of the fluid flow into the voiding device during the flow event; analyzing the plurality of outputs of the fluid level sensor over a time interval defined by the beginning and end time of the fluid flow to determine at least one of a fluid flow rate data and an accumulated volume data for the fluid flowing through the voiding device; and storing the fluid flow rate data and the accumulated flow volume data in a memory.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority from U.S. provisional patentapplication No. 62/679,582 filed 1 Jun. 2018 and titled, “UROFLOWMETER”the entirety of which is incorporated herein by reference for allpurposes.

This application is related to the U.S. patent application Ser. No.______ (Attorney Docket No. P275160.US.01) filed 8 Mar. 2019 and titled,“TESTING DEVICE FOR A UROFLOMETER”; and Ser. No. ______ (Attorney DocketNo. P275159.US.02) filed 8 Mar. 2019 and titled “UROFLOWMETER” theentireties of which are incorporated herein by reference for allpurposes.

TECHNICAL FIELD

The technology described herein relates generally to systems and methodsfor processing and managing data generated from uroflowmeters.

BACKGROUND

Uroflowmeters are used to monitor and diagnose the urinary tract healthof patients. Uroflowmeters measure data regarding the flow of urineduring a urination event, or void. Healthcare providers can use data todiagnose obstructions in the urinary tract and other conditions beforetreatment, and to track treatment progress and effectiveness.

Traditionally, uroflowmeters are bulky, expensive, non-portable devicesthat remain in doctor's offices. These devices are inconvenient andcannot accurately capture a complete record of patient voids, becausepatients are put in an un-natural setting, cannot remain in a doctor'soffice in proximity to the uroflowmeter for a prescribed period morethan a few hours, and may produce errant results as patients modifytheir behavior to use the uroflowmeter.

Related to traditional in-office uroflowmeters, patients may be asked tokeep a manual paper or written log of fluid intake and void information,such as urgency, frequency, or volume of urine, in a record, or void (orurinary) diary, of void events over a prescribed period of time.Patients may record voiding volume by voiding into a voiding measurementbowl placed over a toilet. Patients are reluctant to carry the voidingmeasurement bowl and paper diary with them because the bowl is large,indiscrete, and inconvenient. Due to the lack of portability, there areoften voids missing from the diary. Additionally, often there is a delaybetween a patient completing a void and filling out the diary, whichresults in erroneous information being recorded or missing information.Finally, there is potential for delay in submitting a paper void diaryback to the doctor's office for transcription into an electronic form.Handwriting may be illegible, or worse, the entire diary could be lost.These shortcomings result in delays and reduction in the quality ofpatient care.

SUMMARY

The present disclosure generally relates to systems and methods forprocessing and managing data generated from uroflowmeters.

A method for generating a urine flow void profile for a user flow eventis disclosed. The method includes: receiving by a processing element aplurality of outputs from a fluid level sensor corresponding to aplurality of levels of fluid flowing through a voiding device during aflow event; determining by the processing element a beginning and an endtime of the fluid flow into the voiding device during the flow event;analyzing the plurality of outputs of the fluid level sensor over a timeinterval defined by the beginning and end time of the fluid flow todetermine at least one of a fluid flow rate data and an accumulatedvolume data for the fluid flowing through the voiding device; andstoring the fluid flow rate data and the accumulated flow volume data ina memory.

A method for validating a flow event detected by a voiding device ascorresponding to a urinary event is disclosed. The method includes:validating a flow event detected by a voiding device as corresponding toa urinary event, including: receiving from a fluid sensor and avalidation sensor flow characteristics of the fluid flow through thevoiding device during the flow event; determining that the flow eventcorresponds to a urinary event; for the urinary event transmittingunanalyzed data to a server; and outputting a void profile correspondingto the flow event.

A method for generating a urinary diary for display on a user device isdisclosed. The method includes: determining by a processing element thata urinary event occurred; accessing void profile characteristicscorresponding to the urinary event, the void profile characteristicsbeing detected by a voiding device in electronic communication with aserver; receiving user input void data via the user device; determininga diary time slot corresponding to the urinary event and the user voiddata; and associating the urinary event and void profile characteristicsto generate a correspondence between the user input void data and thevoid profile characteristics.

A method of correlating a voiding device with a patient is disclosed.The method includes: receiving by a processing element patient datacorresponding to the patient; generating by the processing element apatient identifier corresponding to the patient data; generating by theprocessing element a first device identifier corresponding to a firstportion of the voiding device; generating by the processing element asecond device identifier corresponding to a second portion of thevoiding device; associating the first portion of the voiding device withthe second portion of the voiding device; generating by the processingelement a linkage between the patient identifier and the first deviceidentifier to associate the patient data with the voiding device; andoutputting to a display by the processing element a confirmation displayconfirming a linkage between the patient identifier and the deviceidentifier.

A method of assessing urinary treatment effectiveness is disclosed. Themethod includes: receiving by a processing element pre-treatment voiddiary data corresponding to a patient urinary history during a firsttime interval, the pre-treatment void diary data including voidcharacteristics detected by a voiding device during void events by thepatient during the first time interval; receiving by the processingelement a treatment plan prescribed to the patient by a healthcareprovider; receiving by the processing element post-treatment void diarydata corresponding to the patient urinary history during a second timeinterval, the post-treatment void diary data including voidcharacteristics detected by a voiding device during void events by thepatient during the second time interval; analyzing by the processingelement the pre-treatment void diary data and the post-treatment voiddiary data to determine treatment effectiveness; and outputting by theprocessing element to a display an effectiveness assessment.

A system for assessing the urinary health of the patient is disclosed.The system includes: a handheld voiding device which includes: a flowsensor; a device processing element; and a flow chamber wherein thehandheld voiding device receives patient urine and receives by thedevice processing element a plurality of outputs of the flow sensorcorresponding to a plurality of levels of a fluid flowing through thehandheld voiding device during a flow event; a server in communicationwith the handheld voiding device, wherein the server receives flow eventdata from the voiding device and by a server processing element analyzesthe flow event data to validate a void event, and determines a parameterassociated with the valid void event data, and associates the parameterwith a void diary stored in a memory, and outputs a urinary healthreport; and a healthcare provider device in communication with theserver, wherein the healthcare provider device receives the urinaryhealth report from the server.

A method of processing data from a uroflowmeter is disclosed. The methodincludes: providing a uroflowmeter in communication with a voiding diarysystem; detecting flow event data by the uroflowmeter; transmitting theflow event data to the voiding diary system; analyzing by the voidingdiary system the flow event to determine a void event; analyzing urinefluid level and duration data to determine void characteristics; andgenerating a graphical output of the urine flow rate, duration, volumeand timestamp data to develop a treatment plan.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified schematic diagram of an information managementsystem for a voiding device.

FIG. 2A is a perspective view of an example of a voiding device.

FIG. 2B is a partially exploded perspective view of an example of avoiding device.

FIG. 2C is a section view of an example of a voiding device, taken alongline 2C-2C of FIG. 2A.

FIG. 2D is a section view of an example of a voiding device, taken alongline 2D-2D of FIG. 2C.

FIG. 2E depicts the voiding device of FIG. 2A in first configuration.

FIG. 2F depicts the voiding device of FIG. 2A in a second configuration.

FIG. 2G depicts the voiding device of FIG. 2A in a third configuration.

FIG. 2H is a perspective view of another example of a voiding device.

FIG. 2I is a partially exploded perspective view of an example of thevoiding device of FIG. 2H.

FIG. 2J is a section view of an example of a voiding device, taken alongline 2J-2J of FIG. 2H.

FIG. 2K is a partially exploded perspective view of an example of avoiding device.

FIG. 2L is a section view of an example of a voiding device, taken alongline 2L-2L of FIG. 2K.

FIG. 2M is an exploded view of an alternative uroflowmeter in accordancewith various examples of the present disclosure.

FIG. 2N is a cross-sectional view of the uroflowmeter of FIG. 2M takenalong line 2N-2N in accordance with various examples of the presentdisclosure.

FIG. 2O is a partially exploded view of the uroflowmeter of FIG. 2Millustrating a method of decoupling a flow chamber and a handle of theuroflowmeter in accordance with various examples of the presentdisclosure.

FIG. 2P is a partial detailed perspective view of an example of anattachment of a flow chamber and a handle of the uroflowmeter of FIG.2M.

FIG. 3A is a simplified block diagram of the electronics in an exampleof a voiding device.

FIG. 3B is a simplified block diagram of the electronics in an exampleof a server.

FIG. 4 is a flow chart illustrating a method for capturing flow eventdata with the voiding device of FIG. 2A.

FIG. 5 is a flow chart illustrating a method for validating capturedflow event data as corresponding to a void.

FIG. 6A is an example of a void flow rate profile validated using themethod of FIG. 5.

FIG. 6B is an example of an accumulated void volume profile validatedusing the method of FIG. 5.

FIG. 7 is a flow chart illustrating a method for determining voidcharacteristics of a detected void.

FIG. 8 is a flow chart illustrating a method for capturing void diaryinformation corresponding to detected voids.

FIG. 9 is a flow chart illustrating a method for associating a voidinformation with a select patient.

FIG. 10 is a flow chart illustrating a method to determine treatmenteffectiveness with a voiding device of FIG. 2A.

FIG. 11 illustrates an example of a report generated with the method ofFIG. 8.

FIG. 12 illustrates variations of acceleration detected by the voidingdevice during use.

FIG. 13 illustrates positioning error detected by the voiding deviceduring use.

FIG. 14 illustrates using a relationship between acceleration changesand positioning error of a voiding device during use to validatedetected voids.

FIG. 15 is a flow chart of a method for activating, using, andtransferring data using the voiding device of FIG. 2A.

FIG. 16A is a flow diagram illustrating an implementation of portions ofthe method of FIG. 8.

FIG. 16B is a flow diagram illustrating an implementation of portions ofthe method of FIG. 8.

FIG. 16C is a flow diagram illustrating an implementation of portions ofthe method of FIG. 8.

FIG. 16D is a flow diagram illustrating an implementation of portions ofthe method of FIG. 8.

FIG. 16E is a flow diagram illustrating an implementation of portions ofthe method of FIG. 8.

FIG. 17A is a flow diagram illustrating an implementation of portions ofthe method of FIG. 9.

FIG. 17B is a flow diagram illustrating an implementation of portions ofthe method of FIG. 9.

FIG. 17C is a flow diagram illustrating an implementation of portions ofthe method of FIG. 9.

FIG. 17D is a flow diagram illustrating an implementation of portions ofthe method of FIG. 9.

FIG. 17E is a flow diagram exhibiting a specific implementation ofportions of the method of FIG. 9.

FIG. 18 is a schematic diagram of an illustrative implementation ofportions the information management system of FIG. 1.

FIG. 19 is an example of a uroflow study report of void event of apatient

FIG. 20 is an example of a voiding diary report of a patientillustrating void data over a period of consecutive days.

FIG. 21 is an example of a comparison report of uroflow study data of apatient over a span of several months.

FIG. 22 is an example of a comparison report of voiding diary data of apatient over a span of several months.

DETAILED DESCRIPTION

The present disclosure generally relates to systems and methods foranalyzing and managing data generated from uroflowmeters or voidingdevices to assist and increase accuracy in patient diagnostics andtreatment. In one example a voiding device is disclosed thatcommunicates with one more electronic devices (e.g., user smart phone,tablet computer, laptop, server, cloud network, or the like). Thevoiding device includes positioning and flow sensors that detect voiddata corresponding to a urinary or use event, such as flow rate, timemetadata, and the like. Examples of sensors of the voiding device mayinclude: a buoyant float coupled to a displacement sensor, a temperaturesensor, conductivity sensor, opacity sensor, a clock or timer, and thelike. The void data detected by the sensors is then verified todetermine if it corresponds to a likely void event or whether itcorresponds to another non-urinary/void event, such as a patient washingthe voiding device after use. This validation helps to preventirrelevant data from being stored in a patient's void profileinformation, as well as reduce data transfer within the system,increasing the accuracy of the recorded void profiles to increasetreatment effectiveness.

In one example, the system compares sensor data with validity criteriato determine whether data are associated with a void event, or someother type of event, for instance rinsing the voiding device. As aspecific example, the system uses the data to determine whether a floatorientation is correct, e.g., whether the float is inverted, sideways,or at some other orientation inconsistent with a void. In instanceswhere the float orientation is consistent with a user washing thevoiding device versus voiding into the device (e.g., the float issideways or the like), the detected data, such as flow rate, may bediscarded as corresponding to a non-voiding event.

As another example, the system may also use detected flowcharacteristics, such as peak flow rate, duration of flow, or total flowvolume, to determine if collected data are consistent with a void.Specifically, in instances where a peak flow is too high, a duration offlow is too long, or that a flow volume is too large, the system maydetermine that such data corresponds to some other event or otherwiseincludes errors and discards the data or otherwise associates the datawith a non-void event. In another example, the system may determine thata fluid temperature flowing through the voiding device is within anexpected range to be consistent with a void. The system may validate thedata using one or multiple sensors to validate detected data ascorresponding to a void event. Using multiple sensors introducesredundancy into the system to help prevent inadvertent discarding ofreal void data, while reducing the number of sensors can increase theprocessing speed at which data can be validated. As such, the number andtypes of flow information used to validate a particular user flow eventmay be varied as desired.

In the event that the void data corresponds to an actual urinary userflow event by the patient, the system uses the detected flow informationto determine voided urine volume, average urine flow rate, maximum flowrate, voiding duration, voiding flow time, time to maximum urine flow,as well as other detected void profile characteristics. The void profilecharacteristics may be generated in real time or after a series of voidshave been collected. The void characteristics or data may be transmittedto a patient's personal electronic device or another electronic device,directly from the voiding device (e.g., Bluetooth®) or via a network,e.g., from a cloud server to the user's device. Similarly, the voidcharacteristics can be transmitted, directly or indirectly, to ahealthcare provider and/or third party insurer to assist in treatmentand payment decisions. Because the void profile characteristic may beautomatically transferred to a user device and/or a third party orhealthcare provider device and the void profile characteristics arecaptured in real-time as a user is voiding, the data are accurate andcan more effectively be used to assess treatment.

Additionally, the disclosure includes methods to correspond detectedvoid characteristics with user activity, fluid consumption, urinaryinput, or the like, to generate a more complete and holistic urinarydiary, which was previously not possible with conventional devices. Inone example, an application or other program executing on the userdevice may receive user input related to the user's fluid consumption,urinary events, leakage, and the like, where the user is presented withquestions or other interfaces tailored to the detected void profilecharacteristics. A urinary event is any event involving the flow ofurine from a user's urinary tract. Using the user input and the voidcharacteristics, the system may generate a void profile for the user forthe select use period. Due to the dual-input (user input and detecteddata), 1:1 correspondence between a void and a user activity can bedetermined that may increase diagnostic accuracy by a healthcareprovider.

Relatedly, the voiding device and user information may be transmitted toa healthcare provider device. For example, the voiding device may beassigned to a particular patient or user from a healthcare provider, andthe voiding device may be given a device identifier that corresponds toa patient identifier, associating or linking the two together. Fromthere, the user inputs information into his or her mobile device, andthe void data collected by the voiding device then is received,processed, and may be transmitted directly to the healthcare providerdevice, such that the healthcare provider can receive void profile data,user consumption data, and the like, with the data being tied to theparticular patient. After a period of use, e.g., observation or testingperiod, or when treatment is complete, the user may return the voidingdevice back to the healthcare provider. At this point, the healthcareprovider may dissociate the device from the current user, disconnect thedisposable portion of the voiding device (discarding the disposableportion and cleaning/disinfecting the durable portion), recharge thedevice, and return the durable portion of the voiding device back intoservice to be assigned or coupled to another user. Disassociating thevoiding device 200 may also include recharging the battery 272, purgingstored information, and/or testing the device for readiness. In anotherexample, a healthcare provider's office may have one or more voidingdevices in a charging unit, enabling their use for patients while in theprovider's office. The charging unit may be coupled to the voidingdevice, either wirelessly or via a wire (e.g., universal serial bus“USB”) to transmit and receive data from the voiding devices. Thecharging device can then transmit received data to a server for storage,processing, analysis and reporting or optionally may analyze the dataitself.

The voiding device and methods herein may also be used to assesstreatment effectiveness, which can then be used to vary treatment, aswell as generate payment frameworks for insurers or other third parties.In one example, the system may receive user pre-treatment void diarydata including void characteristics detected by the voiding device aswell as user input information and compare the pre-treatment void diarydata to post-treatment void diary data conducted after the user hascompleted a prescribed treatment plan. Comparing the results and voidcharacteristics an experienced professional can then help to determinethe effectiveness of the treatment, or thresholds (e.g., time to urinarymax flow, number of void events, and the like), that may be used toscore or otherwise rank the effectiveness of various treatment plans.This scoring can be used to provide feedback to healthcare providers,generate improved treatment plans, and provide payment schedules basedon effectiveness. Additionally, if a treatment plan is not effective forparticular patients, a healthcare provider or insurer may use thepre-treatment void dairy data and the post-treatment void diary data todetermine the need to prescribe different treatment plans for thosepatients.

Referring to FIG. 1, a system 100 for analyzing and managing datagenerated from uroflowmeters to assist and increase accuracy in patientdiagnostics and treatment is disclosed. The system may include a network102, one or more voiding devices 200 for measuring data related to voidor urinary events, a user mobile device 108, a healthcare providerdevice 109, a report device 110, a charging station 114, and/or a thirdparty device 103. Any combination of the voiding device 200, user mobiledevice 108, healthcare provider device 109, a report device 110,charging station 114, and/or a third party device 103 may be inelectronic communication with one another via network 102 or in someinstances directly (e.g., wired connection). The voiding device 200 maybe in communication with server 112 directly via the network 102. Forexample, the user mobile device 108 may be in communication with network102 and/or the voiding device 200 via network 102 or directly withoutthe use of network 102. The voiding devices 200 may be in directcommunication with the charging station 114.

In one method of using the system, a healthcare provider, such as adoctor, nurse, or other assistant, associates a handheld voiding device200 with a patient whose urinary health is being studied. The patientmay be seeking treatment, undergoing treatment, or assessing changes inurinary health post-treatment. The patient empties his or her bladder ofurine (i.e., voids), into or on the handheld voiding device 200. Thevoiding device 200 collects data regarding various characteristics,e.g., liquid level, flow rate, and accumulated volume of during the flowevents in which a liquid flows through it. The voiding device 200 thendetermines whether the flow event is a void, and validates the data asvoid data. In instances where the flow event is determined to notcorrespond to a void event, e.g., corresponds to a rinse event, or ifthe movement or other characteristics during the flow event would renderunusable data, the voiding device 200 discards the detected flow data.Because the voiding device 200 may do an initial void/not a voidvalidation process and discard incorrect or unusable data, the memoryon-board of the device 200 can be limited since only actual data foranalysis may be stored.

In instances where the voiding device 200 has validated the flow eventdata as being a potential void event, the voiding device 200 transmitsthe collected, un-analyzed data to the server 112 via the network 102,such as via a cellular telephone network. A server processing element152 then analyzes the potential void event data to validate whether thedata are associated with a void event and then determines variouscharacteristics of the void, e.g., peak flow, void volume, average flow,time to maximum flow, the flow time, the void time, or othercharacteristics as desired. The server processing element 152 may beassociated with the server 112, the healthcare provider device 109, thereport device 110, the third party device 103, the user mobile device108, or another device. The server 112 may then record the void profilecharacteristics in a patient's void diary or record of urinary events.The patient may also keep a void diary by inputting information into auser device hosting a diary application. In particular, the void diarymay be on a user mobile device 108 such as a mobile phone, but may alsobe recorded using manual methods. The server 112 may combine voidingdevice 200 data with user-input data, as well as any other reports orstudies inputted by a healthcare provider, insurer, caretaker, or thepatient. A healthcare provider may then access the combined data tomanage and monitor the patient's urinary health. When the patient hascompleted the urinary health study, the voiding device 200 may bereturned to the healthcare provide for re-use, in whole or in part, andassociation with a new user.

In examples where the server processing element 152 analyzes the voiddata, the device processing element 252 on the voiding device 200 can bemade less expensive (possibly disposable) and include more modest powerrequirements, thus extending the battery life as compared to exampleswhere the voiding device analyzes the data on-board. Further, the serverprocessing element(s) 152 are generally more powerful than on-boardmicroprocessors, and therefore can provide more robust analysis andanalyze the data more quickly than a device processing element 252 inthe voiding device 200. The server or servers 112 (e.g., distributedcloud network or cloud computing) may be able to process the data frommultiple voiding devices 200 further reducing costs. Additionally, theserver 112 may be more easily updated with new software and hardware,relative to trying to push an update through to a number of voidingdevices 200 in various locations, such a people's home, doctor's officesand the like. Moreover, utilizing the server 112 for analysis can assistin scalability, enabling an operator of the system to buy server time orprocessing power on a virtual server when increased demand warrants it,and scale back the server in other times of less demand. A virtualserver 112 may be used, rather than, or in addition to, physical servers112. Because security is a concern when handling patient medical data, aserver 112 analyzing void data is also beneficial because it may providefor more robust security, securing a few servers 112 as compared to manyvoiding devices 200.

The network 102 may be any system where two or more processing elementsare in communication with one another. For example, network 102 may be aprivate cellular telephone network, a local area network, radio wavetransmission, a public network, or the internet. Communication onnetwork 102 may be by any suitable means, e.g., wired, wireless,optical, or the like. For example, network 102 may includecommunications via, Ethernet, Wi-Fi®, Bluetooth®, near fieldcommunication, radio frequency identification, infrared, or the like, aswell as other communication components such as universal serial bus(“USB”) cables or receptacles, or similar physical connections usingconductive wires or fiber optic cables. It should be understood that thenetwork 102 may have multiple networks. The voiding device 200 maycommunicate directly with the network 102. For example, the voidingdevice 200 may communicate via a cellular telephone network.Alternately, the voiding device may communicate with the user mobiledevice 108 via Bluetooth® and the user mobile device 108 may thencommunicate with the server via the Internet.

The user mobile device 108 may be substantially any type of electronicor computer device, and may be connected to one or more computernetworks 102. In one example, the user mobile device 108 may be a smartphone, tablet, laptop, or other held-held computing device. A connectionbetween a user mobile device 108 and a computer network 102 may becontinuous, or it may be intermittent.

The healthcare provider device 109 may be substantially any type ofelectronic or computer device used by a healthcare provider inconjunction with a voiding device 200. In one example, healthcareprovider device 109 may be a smart phone, tablet or other held-heldcomputer. In another example, healthcare provider device 109 may be adesktop computer, laptop, or server.

The report device 110 may be similar to the healthcare provider device109, but used by an insurance provider in conjunction with a voidingdevice 200. In one example, the report device 110 may be a smart phone,tablet or other held-held computer. In another example, the reportdevice 110 may be a desktop computer, laptop, or server.

The third party device 103 is similar to the healthcare provider device109 and/or report device 110 and is typically tied to parties other thanthe patient or healthcare provider, e.g., people or organizations whoare involved in the care of a user of a voiding device 200. For example,a third party may be a caregiver who is not a healthcare professional,such as a family member. In one example, third party device 103 may be asmart phone, tablet or other held-held computer. In another example,third party device 103 may be a desktop computer, laptop, or server.

The charging station 114 stores and charges the voiding devices 200 sothey are charged and ready for use. The charging station 114 interactswith the voiding devices to charge them, such as through the use ofcooperating inductive coils in the charging station 114 and the voidingdevices 200 or via a wired connection to the voiding devices 200. Thecharging station 114 also interacts with the voiding devices 200 byanalyzing and/or transmitting radio frequency data between the voidingdevices 200 and the charging station 114. The transmitted data includesinformation about a particular voiding device 200, such as a deviceidentifier, device status, patient association information, batterystate of charge, and the like. The transmitted data may also includeother information such as patient flow data or void data and can betransmitted in both directions between the charging station 114 and thevoiding devices 200. The transmitted data may further include softwareor firmware updates for the device processing elements 252 of thevoiding devices 200, stored in memory 254. In various examples, theradio frequency data are transmitted by near-field communication(“NFC”); Wi-Fi®; Bluetooth®; cellular telephone network technologies; orother wireless technologies.

The voiding device 200 captures data corresponding to a user's urineflow events or void events, and determines void data corresponding tothese events. In one example, the voiding device 200 is handheld, suchthat a user can hold the voiding device 200 over a toilet or otherreceptacle during a void to capture urine flow. In another example, thevoiding device 200 may attach to a toilet seat in order to receive auser's urine during a void event. The voiding device 200 may have one ormore apertures of predetermined size and shape allowing urine to flowout of the voiding device 200. Examples of the voiding device 200 aredisclosed in U.S. patent application Nos. 62/679,582 filed 1 Jun. 2018and titled, “UROFLOWMETER”; Ser. No. 29/649,761 filed 1 Jun. 2018 andtitled, “UROFLOWMETER”.

In various instances data can be transferred between the voiding devices200, server 112, and associated user devices (e.g., user mobile device108, healthcare provider device 109, report device 110, third partydevice 103, etc.) in multiple manners. FIG. 18 illustrates a specificimplementation of the information management system 100 of FIG. 1. Theimplementation has one or more patients who may have user mobile devices108. The implementation has two networks 102 a and 102 b. The network102 a is the internet, or cloud. The network 102 b is a private cellularprovider network. There are two servers 112 a and 112 b. The server 112a is a server provided by the implementer of the information managementsystem 100. The server 112 a may run a web application for staff of theimplementer to manage clinic set up, inventory, and distributionfunctions. The server 112 b may run a web application for staff of theimplementer to manage SIM card allocation, billing, system access, andhigher level corporate administrative functions. There is a USB-basedradio frequency identification (“RFID”) reader 118. There is a webportal 120 with multiple custom user interfaces (“UI”). There aremultiple service application program interfaces (“APIs”) 116. In itssimplest form, an API is a set of computer executable instructions thatallow two devices or two software programs to communicate with oneanother. There are multiple voiding devices 200. Some voiding devices200 are placed in an inductive charging station 114 when not in use. Inthis implementation, there are two healthcare provider devices 109 a and109 b. The healthcare provider device 109 a is a tablet computer,accessible by a clinician, such as a doctor, a clinical assistant,and/or office staff. Healthcare provider device 109 b is a desktoppersonal computer, accessible by a clinician and/or clinical assistant.

The voiding devices 200 communicate with a service API 116 via thecellular network 102 b. The service API 116 enables communicationbetween the cloud 102 a and the voiding device 200. The voiding devices200 also communicate via NFC with the healthcare provider device 109 a.The NFC data transmitted between the voiding devices 200 and thehealthcare provider device 109 a may include the same data transmittedbetween the charging station 114 and the voiding devices 200. Thehealthcare provider device 109 a may use NFC to associate or dissociatea voiding device 200 with a patient. The healthcare provider device 109a communicates with a service API 116 via cellular network 102 b. Thehealthcare provider device 109 a may use cellular communications insteadof, or in addition to, NFC to communicate with the voiding devices 200.The healthcare provide device 109 a may also contain an RFIDcommunications device to communicate with the voiding devices 200. Theserver 112 a serves the web portal 120 with multiple custom UIs. Theserver 112 a communicates with a USB-based RFID reader 118 that can addnew voiding devices 200; manage existing voiding devices 200; and/orremove damaged, lost, used, or expired voiding devices 200 from theinformation management system 100. The healthcare provider device 109 acommunicates via the cellular network 102 b with the web portal UI 120,and to the server 112 a, and the other devices within the informationmanagement system 100. The healthcare provider device 109 b communicateswith the web portal UI 120 via wired or wireless communicationstechnologies, such as Wi-Fi®, or Ethernet to the server 112 a, and theother devices within the information management system 100. The usermobile devices 108 communicate with the service APIs 116 via cellularnetwork 102 b, or through Wi-Fi®. The user mobile devices 108 alsocommunicate with the web portal 120. The 112 b communicates with thecloud 102 a, and with cellular network 102 b, providing user interfacesbetween the networks 102 a and 102 b.

In an exemplary use case of the implementation of the informationmanagement system 100 of FIG. 18, a patient seeks medical treatment froma clinician. The clinician, or staff, associates a voiding device 200 tothe patient using the healthcare provider device 109 a or 109 b. Thepatient uses the voiding device 200 to record flow information fromvoiding events. The voiding device 200 transmits the flow data to theserver 112 a for analysis and validation, via the service API 116. Thepatient records information related to void events using the user mobiledevice 108 that accesses a custom UI served by the web portal 120, orhas a custom application installed on the user mobile device 108. Theserver 112 a combines the user mobile device 108 data with voidingdevice 200 data to develop a comprehensive voiding diary that theclinician can access via healthcare provider device 109 a or 109 b, anduse to diagnose, treat, and assess the patient's condition.

FIG. 2A illustrates a perspective view of an illustrative voiding device200. FIG. 2B illustrates an exploded view of the voiding device 200 ofFIG. 2A. The voiding device 200 includes a flow chamber 204 thatmomentarily collects and measures urine or other fluid flow while a useris voiding. The flow chamber 204 includes an inlet 204 a and an outlet204 b. The flow chamber 204 optionally includes a funnel 206 to producea smooth flow of urine into the flow chamber. The funnel 206 may definea contour that directs or guides a flow of urine into the flow chamber204. The contour of the funnel 206 may facilitate reducing turbulentflow of the urine within the flow chamber 204. This may produce a smoothor settled flow of the patient's urine within the flow chamber 204. Insome cases, the funnel 206 may form a consistent, laminar flow of theurine. The funnel 206 may include features that orientate or alignanatomy of a male patient relative to the voiding device 200 in order tofacilitate directing or guiding the male patient's urine into the inlet204 a of the flow chamber 204. The inlet 204 a receives urine from theuser during use and the outlet 204 b allows the collected urine to exitthe voiding device 200, such as into a toilet, for disposal. The inlet204 a may be defined along a top of the voiding device 200 to facilitateurine collection. The outlet 204 b may be defined along a side (such asa front sidewall as illustrated in FIG. 2A, 2B) of the voiding device200 to facilitate urine disposal and allow a user to more easily directthe outflow into the proper receptacle. The voiding device 200 typicallyincludes a handle 202 for grasping by a patient. The handle 202 extendsfrom a rearward direction from the flow chamber 204 and may be elongatedand relatively slender to provide an ergonomic grip for a patient'shand. In some aspects, a light emitting diode (“LED”) is integrated withthe elongated handle. The LED may indicate an orientation value of thevoiding device 200 corresponding to a target condition, such as a targetorientation value.

The voiding device 200 may include various sensors that detect void datacorresponding to a void event. The voiding device 200 may includevarious types of sensors to determine urine flow rate and urine voidvolume. In many examples, the voiding device 200 includes one or moreflow sensors or fluid level sensors 262. The one or more fluid levelsensors 262 may be substantially any type of electronic device, ormultiple devices, capable of detecting the fluid level in the flowchamber 204 of the voiding device 200. The fluid level sensor 262 mayoutput an electrical or optical signal corresponding to the level of thefluid in the flow chamber 204. The outputs of the fluid level sensor 262may correspond to positions of the fluid level sensor 262 during a timeinterval. The fluid level sensor 262 may include one or more image oroptical sensors (e.g., time of flight sensor systems), inductivesensors, magnetic sensors, and/or other sensors. In various examples,the fluid level sensor 262 uses magnetic Hall effect sensing todetermine the fluid level in the flow chamber 204. For example, thefluid level sensor 262 may include a magnetic displacement sensor 222,such as a rotary Hall effect sensor, that measures the rotary angle of anearby magnet 226.

It should be noted that the displacement sensor 222 may measure either alinear or an angular displacement of the float. In another example, thefluid level sensor 262 is an accelerometer connected to a flexiblefloat. As the float rises or falls, such as in response to fluid levels,the accelerometer registers a change in its position and thus the fluidlevel. In another example, the fluid level sensor 262 is a plurality ofcorresponding pairs wetted electrodes placed at various locations withinflow chamber 204. As fluid rises within the flow chamber 204 the fluidmay bridge across corresponding pairs of electrodes, enabling a currentto flow between them, thereby detecting the fluid level. In anotherexample, the fluid level sensor 262 is a plurality of temperaturesensors, such as thermistors, thermocouples, or resistance temperaturedevices placed at various locations within flow chamber 204. As fluidrises within the flow chamber 204 it may cause a temperature change invarious of the plurality of temperature sensors, thereby detecting thefluid level. In another example, the fluid level sensor 262 is aresistive strip that encounters a change in electrical resistance whenexposed to an electrically conductive fluid, such as urine. In anotherexample, the fluid level sensor 262 is an optical detector, such as acamera, or light emitter and receiver, that measures liquid level inflow chamber 204 relative to graduation marks (e.g., lines showing thevolume of fluid at a given point) within flow chamber 204. In anotherexample, the fluid level sensor 262 is a light emitter and receiver thatmeasure changes in optical transmissive power through a fiber-opticelement at that element is exposed to varying levels of fluid withinflow chamber 204. In another example, the fluid level sensor 262 is astrain gauge, such as a Wheatstone bridge coupled to a buoyant element.The strain gauge measures the strain on the float as it moves, such asin response to various levels of fluid within flow chamber 204.

The voiding device 200 may have one or more validation sensors 260 thatenable the device processing element 252 of the voiding device 200 toanalyze one or more validation characteristics to validate whethercollected data corresponds to a valid void event. These validationsensors 260 may measure validation characteristics of the voiding device200 and/or the validation characteristics of the voiding device 200environment, which can then be compared against typical voidingvalidation characteristics and/or voiding environments to determine ifthe event is a void event and if it is a void whether the data is usable(e.g., not too noisy or error prone). In one example, a validationsensor 260 includes one or more of the orientation sensors. In oneexample, the orientation sensor is an accelerometer. In another example,the orientation sensor is a gyroscope. In one example, the validationsensor 260 detects the grip of a user. In one example, a grip sensor isa capacitive or resistive sensor with an output corresponding to auser's grip. In another example, a validation sensor 260 is a button,switch or the like that the user activates indicating that the voidingdevice 200 is about to receive a void. In another example, thevalidation sensor 260 is a proximity sensor, detecting the proximity ofthe voiding device 200 to the user's hand, body, or genitals, indicatingthe voiding device 200 as about to receive a void.

The fluid level sensor 262 determines the fluid level in the flowchamber 204. In one example, the fluid level sensor 262 includes abuoyant float 230 coupled with a displacement sensor 222, such that thedisplacement sensor 222, in combination with the float 230, can be usedto determine a level of liquid, or changes to a level of liquid overtime within the voiding device 200. The displacement sensor 222 iscoupled to the flow chamber 204 and is fluidly sealed from the annularspace 216. For example, the flow chamber 204 defines a housing 224 inwhich the displacement sensor 222 is seated. The housing 224 fluidlyseals the displacement sensor 222 from fluid in the flow chamber 204,while permitting the displacement sensor 222 to detect fluid levels inthe flow chamber 204.

As illustrated in FIG. 2A-2D, and particularly in FIGS. 2E-2G, forexample, as the level of urine or other fluid increases in the flowchamber 204, the float 230 rises within the flow chamber 204. Similarly,as the level of urine decreases in the flow chamber 204, the float 230falls within the flow chamber 204. As the float 230 rises and falls, themagnet 226 is rotated relative to the displacement sensor 222 via thefirst and second arms 234 a, 234 b about a pivot axis 232. Thedisplacement sensor 222 detects an angular position ϕ of the magnet 226using its magnetic flux, and the fluid level in the flow chamber 204 canbe determined from the angular position data of the magnet 226, e.g., byusing a look-up table that correlates the angular position of the magnet226 to the position of the float 230, and thus the fluid level in theflow chamber 204.

To illustrate the foregoing, FIGS. 2E-2G show the displacement sensor222 having a reference direction A_(s) and the magnet 226 having areference direction A_(m). For purposes of illustration, the angularposition ϕ of the magnet 226 may be defined as an angle bounded by thereference direction A_(s) and the reference direction A_(m). As the filllevel in the flow chamber 204 increases, the magnet 226 rotates, and assuch, the reference direction A_(m) moves relative to the referencedirection A_(s), thereby indicating a change in the angular position ϕof the magnet 226.

FIGS. 2E-2G show the displacement sensor 222 detecting a distinctmagnetic characteristic T for different angular positions of the magnet226. For example, in the first configuration of FIG. 2E, thedisplacement sensor 222 may detect a magnetic characteristic T₁, whichmay correspond to the magnetic flux exhibited by the magnet 226 whenarranged at an angular position ϕ₁. The angular position ϕ₁ maycorrespond to a position of the float 230 at a bottommost portion of theflow chamber 204, such as when the flow chamber 204 is empty.

As the flow chamber 204 fills with a fluid (e.g., urine), such asgenerally from the flow path F₁, the float 230 rises, thereby rotatingthe magnet 226 and allowing the magnet 226 to exhibit a differentmagnetic characteristic detectable by the displacement sensor 222. Toillustrate and with reference to FIG. 2F, the voiding device 200 isshown in a second configuration in which the flow chamber 204 includesurine 201 at a fill level 203 a. The float 230 is shown in FIG. 2F in anelevated position from that of FIG. 2E, which corresponds to the filllevel 203 a of the urine 201. The elevated position of the float 230 atthe fill level 203 a causes the magnet 226 to rotate for arrangement atan angular position ϕ₂. At the angular position ϕ₂ the magnet 226 mayexhibit a magnetic characteristic T₂ detectable by the displacementsensor 222. In this regard, the displacement sensor 222 detects themagnetic characteristic T₂, which may in turn be used by the voidingdevice 200 (or server, or associated system or device) to determine afill level of the flow chamber 204 being the fill level 203 a shown inFIG. 2F.

As the flow chamber 204 continues to fill with fluid, such as generallyfrom the flow path F₁, the float 230 may continue to rise, therebyfurther rotating the magnet 226 and allowing the magnet 226 to exhibit adifferent magnetic characteristic detectable by the displacement sensor222. To illustrate and with reference to FIG. 2G, the voiding device 200is shown in a third configuration in which the flow chamber 204 includesurine 201 at a subsequent fill level 203 b. The float 230 is shown inFIG. 2G in an elevated position from that of FIG. 2F, which correspondsto the subsequent fill level 203 b of the urine 201. The elevatedposition of the float 230 at the subsequent fill level 203 b causes themagnet 226 to rotate for arrangement at an angular position ϕ₃. At theangular position ϕ₃ the magnet 226 may exhibit a magneticcharacteristic-T₃ detectable by the displacement sensor 222. In thisregard, the displacement sensor 222 may detect the magneticcharacteristic T₃, which may in turn be used by the voiding device 200(or associated system or device) to determine a fill level of the flowchamber 204 being the subsequent fill level 203 b shown in FIG. 2G.

The urinary flow rate of the patient can be determined using the fluidlevel information (e.g., by calculating changes in the fluid level basedon a given outflow rate out of the flow chamber 204, such as the outflowrate of flow along the flow path F2). The fluid level also can beconverted to a total volume collected by the voiding device 200 (e.g.,by integrating the flow rate curve over the total time period of patientuse), or in other words the total volume of urine evacuated or voided bythe patient. The fluid level, in addition to pitch and/or roll values,detected by validation sensor 260 are used as inputs to amulti-dimensional lookup table to determine retained volume and outflowrate. For example, the calculation/process may be: (pitch, roll(optional), fluid level)=>[lookup table]=>(retained volume, outflowrate).

FIGS. 2H-2J illustrate another example of a voiding device 1100including energy dissipation features 1128. The energy dissipationfeatures 1128 are shown positioned substantially within the flow chamber1104. At least a portion of the energy dissipation features 1128 may beconcealed by the funnel 1106 and at least another portion of the energydissipation features 1128 may be visible and/or along or within theinlet 1104 a. Broadly, the energy dissipation features 1128 may define aphysical obstacle or obstruction for a flow of urine entering the flowchamber 1104 through the inlet 1104 a. The energy dissipation features1128 may have a size, shape, and contour that dissipates energy, e.g.,kinetic energy, from the flow of urine. While many shapes are possible,in the example of FIGS. 2H-2J, the energy dissipation features are shownas a collection of elongated cylinders. The elongated cylinders maygenerally extend from a bottom of the flow chamber 1104 toward the inlet1104 a. At the bottom of the flow chamber 1104, the elongated cylindersmay generally be fixed, whereas near to the inlet 1104 a each of theelongated cylinders may have a free end, allowed to deform, flex, sway,and so on. The elongated cylinders are separated from one another,thereby allowing flow among the collection of cylinders. In some cases,the elongated cylinders may have a taper or other contour that changesalong a height of the cylinder.

The energy dissipation feature 1128 may facilitate urine level and flowdetection. For example, the energy dissipation features 1128 may helpreduce turbulent flow within the flow chamber 1104, for example, such asthat which may be caused by a fluid flow impacting a stationary volumeof fluid. In some cases, the energy dissipation features 1128 may alsohelp mitigate fluid exit through the inlet 1104 a. For example, theenergy dissipation features 1128 may reduce kinetic energy of a flow ofurine in a manner that arrests stray flow from exiting the voidingdevice 1100 through the inlet 1104 a, thereby facilitating smooth oruninterrupted operation of float 1130 and associated components.

With reference to FIGS. 2K-2L, another voiding device 1400 is shown.FIG. 2K is an exploded view of the voiding device 1400, and FIG. 2L is across-sectional view of the voiding device 1400, taken along line 2L-2Lof FIG. 2K.

As illustrated in FIGS. 2K-2L the voiding device 1400 includes a handle1402, a bowl or flow chamber 1404, and a funnel 1406. The funnel 1406includes one or more funnel inlets to allow fluid to pass from thefunnel 1406 into the flow chamber 1404. The funnel inlets may be of anysuitable shape and number to allow a smooth flow of fluid from thefunnel 1406 into the flow chamber 1404. The funnel inlets may be in oneconfiguration for male patients, and in a different configuration forfemale patients. In one example, the funnel 1406 has a primary funnelinlet 1406 b. In another example, the funnel 1406 includes one or moresecondary inlets 1406 c.

The voiding device 1400 generally includes the same or similarcomponents and operates in the same or similar manner as the voidingdevice 200 and 1100 and thus the descriptions of the voiding device 200,and/or the voiding device 1100 are applicable to the voiding device1400. In this regard, substantially analogous to the examples of thevoiding device 1100 described above, the voiding device 1400 of FIGS.2K-2L further includes: a proximal portion 1402 a, a distal portion 1402b, a top shell 1403, an inlet 1404 a, an outlet 1404 b, a bottom shell1405, a handle groove 1409 a, a handle tongue 1409 b, a flow chambertongue, a flow chamber groove 1410 b, a sensor 1422, a sensor receivingfeature 1423, energy dissipation features 1428, a magnet 1426, a float1430, a structural member 1430 a, a buoyant member 1430 b, a vent 1440,electronics 1450, a first printed circuit board 1452, a second printedcircuit board 1454, flex connectors 1456, an RFID feature 1460, a SIMfeature 1462, a battery 1464, an antenna 1466, an NFC feature 1467, aproximity sensor 1468, a charging coil 1470, a vent disc 1472, otherelectrical/mechanical components 1474; redundant explanation of which isomitted here for clarity. The structural member 1430 a may be adapted tomaintain accurate readings from the sensor 1422 during high periods offluid flow.

With reference to FIGS. 2M-2P, a uroflowmeter 1700 is shown. FIG. 2M isan exploded view of the uroflowmeter 1700, and FIG. 2N is across-sectional view of the uroflowmeter 1700, taken along line 37-37 ofFIG. 2M. FIG. 2O is a partial exploded view of the uroflowmeter 1700 ofFIG. 2M. FIG. 2P is a partial detailed view of the attachment betweenthe flow chamber 1704 and the handle 1702 of the uroflowmeter 1700.

As illustrated in FIGS. 2M-2P, the uroflowmeter 1700 includes a handle1702, a bowl or flow chamber 1704, and a funnel 1706. The funnel 1706includes one or more funnel outlets to allow fluid to pass from thefunnel 1706 into the flow chamber 1704. The funnel outlets may be of anysuitable shape and number to allow a smooth flow of fluid from thefunnel 1706 into the flow chamber 1704. The funnel outlets may be in oneconfiguration for male patients, and in a different configuration forfemale patients. In one example, the funnel 1706 has a primary funneloutlet 1706 b. In another example, the funnel 1706 includes one or moresecondary outlets 1706 c. In one example, the funnel includes fivesecondary outlets.

The uroflowmeter 1700 generally includes the same or similar componentsand operates in the same or similar manner as the uroflowmeter 200,1100, and 1400, and thus the descriptions of the uroflowmeter 200, theuroflowmeter 1100, and/or the uroflowmeter 1400, are applicable to theuroflowmeter 1700. In this regard, substantially analogous to theexamples of the uroflowmeter 200, 1100, and/or 1400 described above, theuroflowmeter 1700 of FIGS. 2M-2P further includes: a proximal portion1702 a, a distal portion 1702 b, a top shell 1703, an inlet 1704 a, anoutlet 1704 b, a bottom shell 1705, a handle groove 1709 a, a handletongue 1709 b, a flow chamber tongue, a flow chamber groove 1710 b, asensor 1722, a sensor receiving feature 1723, energy dissipationfeatures 1728, a magnet 1726, a float 1730, a structural member 1730 a,a buoyant member 1730 b, a vent 1740, electronics 1750, a first printedcircuit board 1752, a second printed circuit board 1754, flex connectors1756, an RFID feature 1760, a SIM feature 1762, a battery 1764, anantenna 1766, an NFC feature 1767, a proximity sensor 1768, a chargingcoil 1770, a vent disc 1772, other electrical/mechanical components1774; redundant explanation of which is omitted here for clarity. Thestructural member 1730 a may be adapted to maintain accurate readingsfrom the sensor 1722 during high periods of fluid flow.

FIG. 2O illustrates the voiding device of FIG. 2M, where the flowchamber 1704 of the uroflowmeter 1700 is removably attached to thehandle 1702, thereby allowing the flow chamber 1704 to be disposed ofafter patient use. In various examples, the uroflowmeter 1700 does notinclude a disposable funnel. As illustrated in FIGS. 2O-2P, the flowchamber 1704 may have one or more grasping features 1778 a and 1778 bthat grasp cooperating features of the handle 1702. In one example, thegrasping features 1778 a, 1778 b are springs including a cantileveredsection 1784 separated from the body of the flow chamber 1704 by aclearance 1788. In the example, the grasping features 1778 a, 1778 binclude a tang 1786. When the grasping features 1778 a, 1778 b are in arelaxed position, the tangs 1786 grasp corresponding features of thehandle, preventing a user from decoupling the flow chamber 1704 and thehandle 1702. The flow chamber 1704 and the handle 1702 may be decoupledwith the use of a key 1776. The key may be available to medicalprofessionals, and not available to users. The key 1776 may include ahandle 1792 connected to a shaft 1790, a pivot recess 1782 defined atone of the shaft 1790, and one or more decouplers 1780 a, 1780 bdisposed radially about the pivot recess 1782. The one or moredecouplers 1780 a, 1780 b cooperate with the one or more graspingfeatures 1778 a, 1778 b to allow a medical professional to decouple theflow chamber 1704 and the handle 1702 of the uroflowmeter 1700. In oneexample, a medical professional inserts the key 1776 into theuroflowmeter 1700 such that the pivot recess 1782 cooperates with a pinin the uroflowmeter 1700. The medical professional may rotate, or twistthe key 1776, causing the one or more decouplers 1780 a, 1780 b to pressagainst the one or more grasping features 1778 a, 1778 b, flexing thecantilevered section 1784 and causing the tang 1786 to disengage fromthe handle 1702. The medical professional may then slide the flowchamber 1704 away from the handle 1702. The medical professional maythen dispose of, or disinfect and process for reuse, the flow chamber1704. The medical professional may then reprocess the handle 1702 forreuse as previously described. The key 1776 and associated features ofthe handle 1702 that prevent user decoupling of the handle 1702 and theflow chamber 1704 are shown with respect to the example of the voidingdevice 1700, in FIGS. 2M-2O for example and illustration purposes. Thekey and these or similar features are equally applicable to, and may beincluded in, any voiding device disclosed herein, including the voidingdevice 200, 1100, 1400, and/or 1700.

FIG. 3A is a simplified block diagram of additional components embeddedwith or otherwise coupled to the voiding device 200. These componentsmay be enclosed within the handle 202 or in another location within thehousing of the device. Referring to FIG. 3A, the voiding device 200 mayinclude one or more device processing elements 252, one or more memorycomponents 254, a power source 256, an input/output (110) interface 258,one or more validation sensors 260, one or more fluid level sensors 262.The device processing element 252 may contain a clock. The voidingdevice 200 may include other components typically found in computingsystems, such as communication interfaces and other sensors, amongothers. For example, the voiding device 200 may contain a cellulartelephone network modem capable of communicating directly with acellular network. Each element of the voiding device 200 may be incommunication with each of the other elements of the voiding device 200via one or more system buses 266, wirelessly, or the like. The voidingdevice 200 can transfer data to various computing devices (e.g., theuser mobile device 108, the healthcare provider device 109, the reportdevice 110, the third party device 103, and/or server 112).

At least some of the components or elements of the voiding device 200may be housed in the voiding device 200. For example, one or more of thedevice processing elements 252, memory components 254, power source 256,input/output (I/O) interface 258, validation sensors 260, and fluidlevel sensors 262 may be positioned in or received in the voiding device200. For example, one or more of the device processing elements 252,memory components 254, power source 256, input/output (I/O) interface258, the fluid level sensors 262, and validation sensors 260 are housedor received in the handle 202, and the magnet 226 is received in theflow chamber 204. The device processing elements 252 may be associatedwith a printed circuit board 270 and the printed circuit board 270 maybe received in the handle 202 of the voiding device 200 as illustratedin FIG. 2C, for example.

Another example of a voiding device 1100 is illustrated in FIGS. 2H-2J.The voiding device 1100 may include electronics 1150. While manydifferent components may be used to implement the operations of thevoiding device, as described herein, FIGS. 2I and 2J present a samplearrangement of components that define or are associated with theelectronics 1150. Broadly, the electronics 1150 may include a firstprinted circuit board 1152 and a second printed circuit board 1154. Thefirst printed circuit board 1152 and the second printed circuit board1154 may be connected to one another by flex connectors 1156. In theexample of FIGS. 2I and 2J, the first printed circuit board 1152 may bepositioned within the handle 1102 near a proximal portion 1102 a and thesecond printed circuit board 1154 may be positioned within the handle1102 near a distal portion 1102 b.

This dual circuit board arrangement may facilitate arranging componentsat different locations of the handle 1102 based on a target function.For example, the first printed circuit board 1152 may be positioned awayfrom the flow chamber 1104 and be associated with battery operation,charging, and so on, whereas the second circuit board 1154 may bepositioned closer to the flow chamber 1104 and be associated withsensors and operations of the flow chamber 1104. While the example ofFIGS. 2H-2J shows the first printed circuit board 1152 and the secondprinted circuit board 1154 as separate circuit boards that are connectedby the flexible connectors 1156, in other examples, other configurationsare possible. For example, the first print circuit board 1152 and thesecond printed circuit board 1154 may be portions of a single circuitboard, such as a hybrid rigid/flexible circuit assembly having rigidportions and flexible portions. This single component or single assemblyapproach may facilitate reliability by reducing connections, and/or alsoreduce manufacturing costs.

In the example of FIGS. 2H-2J, the first printed circuit board 1152 maybe associated with at least an RFID element 1160, a battery 1164, anantenna 1166, a proximity sensor 1168, a charging coil 1170, a vent disc1172, and/or other electrical mechanical components 1174. Further, thesecond printed circuit board 1154 may be associated with at least thesensor 1122 and a SIM (“Subscriber Identity Module”) feature 1162. Inother examples, other arrangements of components are contemplated toexecute the functions of the uroflowmeter described herein.

In some examples, the RFID element 1160 or other near field radio wavetransmission device, identification beacon, or the like, may facilitatereprocessing and tracking of the handle 1102. For example, the RFIDelement 1160 may include identifying information for the handle 1102,e.g., an identification number or data or the like. The identifyinginformation may be used to associate the handle 1102 with a particularpatient or a particular use of the voiding device 1100. The identifyinginformation may also be used to track the handle 1102 throughoutreprocessing, including tracking the handle 1102 throughout asanitization process. The identifying information may also facilitatereal-time updates of inventory, such as being used to determine whichunits are in a condition for new patient-use, e.g., the units that havebeen reset to factory standards, sterilized, or otherwise processed asdesired. Dynamic adjustments can therefore be made to facilitateinventory level maintenance, including initiating a resupply of handles,or other components, when the inventory drops below a threshold. Theresupply of handles may happen automatically. For example, byperiodically or randomly polling a supply of handles, such as with anRFID scanner, responses from the RFID or other element can be used toeasily determine supply levels and categories of handles (e.g., awaitingprocessing, processed, etc.).

Reprocessing may be facilitated by Global Positioning System (“GPS”)localization of the handle 1102. In some examples, the handle 1102 mayinclude a GPS assembly or other location sensor or element to facilitatedetermining a coordinate and/or relative position of the handle 1102. Asdescribed herein, the handle 1102 may be communicatively coupled withvarious remote computing systems. The GPS assembly of the handle 1102may therefore determine information corresponding to a position of thehandle 1102, which is in turn transmitted wirelessly to the remotecomputing system. The remote computing system may track the location ofthe handle 1102 and determine the handle 1102 being at one or morereprocessing, patient, healthcare provider, or other locations. The GPSassembly may be used to dynamically and automatically provide locationinformation to the server, both during patient use and post processing.This may allow data to be automatically input into a patient use diaryor other associated application that may provide additional metadata tobe stored with patient voids. The GPS assembly may communicate with theU.S. Global Positioning System, the Russian GLONASS system, or othersatellite-based positioning systems. The handle may also determine acoordinate and/or relative position using cellular network triangulationmethods.

Referring to FIG. 3A, the one or more device processing elements 252 aresubstantially any type of electronic device capable of processing,receiving, and/or transmitting instructions. For example, the deviceprocessing elements 252 may be a microprocessor or a microcontroller.Additionally, it should be noted that select components of the voidingdevice 200 may be controlled by a first device processing element 252and other components may be controlled by a second device processingelement 252, where the first and second device processing elements 252may or may not be in communication with each other. Additionally oralternatively, select data processing steps or processes may beperformed by one device processing element 252 with other dataprocessing steps performed by different device processing elements 252,where the different device processing elements 252 may or may not be incommunication with each other.

The one or more memory components 254 may store electronic data used bythe voiding device 200 to store instructions for the device processingelement 252, as well as to store data collected by the fluid levelsensor 262, for example. In some examples, the one or more memorycomponents 254 may be one or more magnetic hard disk drives, solid statedrives, magneto optical memory, flash memory, electrically erasableprogrammable read-only memory (“EEPROM”), erasable programmableread-only memory (“EPROM”), ferromagnetic RAM, holographic memory,printed ferromagnetic memory, or non-volatile memory. In other examples,memory 254 may be any volatile computer readable media device thatrequires power to maintain its memory state. In one example, memory 254is random access memory (“RAM”). Other examples may include dynamic RAM,and static RAM, or a combination of one or more types of memorycomponents.

The power source 256 provides power to select components of the voidingdevice 200. Depending on the particular application, the power source256 may be a battery (for example, battery 272 received in the handle202 of the voiding device 200 as illustrated in FIG. 2C), a power cord,or any other element that transmits electrical power to the components250 of the voiding device 200. As illustrated in FIG. 2C, the battery272 may be accessible via a removable cover 276, which may be located onan underside of the handle 202. The cover 276 may be attached to thehandle 202 via one or more fasteners 278. Alternately, as illustratedfor example in FIGS. 2I-2J, the handle 1102 of an example of a voidingdevice 1100 may include an upper 1103 and lower 1105 unitary shell,housing an inaccessible battery 1164. The battery 272 or 1164 may berechargeable by power cord or inductive charging station 114 shown forexample in FIG. 18. The device processing element 252 may determine astatus of the handheld voiding device, receive information from thecharging station via the I/O interface 258; and indicate readiness forcontinued use through an indicator, for example, an LED.

The clock is any device capable of keeping time or otherwise measuringtime or date data. In one example, clock is a piezoelectric crystaloscillator. In other examples, clock is an atomic clock, radio receiverin communication with a time standard, or any other electrical ormechanical device, and outputting time or date data. In another example,the clock is integrated into the device processing element 252.

The voiding device 200 has a determinable outflow rate. For example,based on the level of urine within the flow chamber 204, the outflowrate of the voiding device 200 can be determined at a given point intime. As illustrated in FIG. 2A, in one example, the outlet 204 b isformed as a vertically-oriented slot. In various examples, the width ofthe outlet 204 b increases as the outlet 204 b progresses upwardly fromthe bottom wall 218 toward the rim 210 of the flow chamber 204 (e.g.,forming a triangularly-shaped opening). The slot allows an increasingoutflow rate of the voiding device 200 as the fluid level increaseswithin the flow chamber 204 to ensure urine does not overflow out of theflow chamber 204. The outlet 204 b restricts urine flow out at low flowrates to improve “low-flow” sensitivity of the system, and increasesflow out for higher flow rates (i.e., where less sensitivity isrequired) to prevent overflow or backflow conditions).

FIGS. 2H-2J illustrate another example of a voiding device 1100. Theoutlet of the voiding device 1100 can be defined by a T-shaped slot.Further, the examples of a voiding device 1100 FIGS. 2H-2J shows thevoiding device 1100 having the outlet 1104 b. The outlet 1104 b isgenerally defined by a T-shaped slot extending through an exterior wallof the flow chamber 1104. The outlet 1104 b generally increases avolumetric range of the flow chamber 1104, across which high accuracyflow measurements may be obtained. For example, the outlet 1104 bgenerally restricts flow from exiting the flow chamber 1104 when theflow chamber 1104 includes relatively little fluid. The structuralmember 1130 a may be adapted to maintain accurate readings from thesensor 1122 during high periods of fluid flow. In another example, thefloat 1130 b generally restricts flow from exiting the flow chamber 1104when the flow chamber 1104 includes relatively little fluid. This maycorrespond to a lower flow rate of urine, and therefore the restrictionof fluid exiting the flow chamber 1104 helps facilitate or increase thesensitivity of associated flow measurements in this configuration. Asthe volume of fluid in the flow chamber 1104 increases, the outlet 1104b reduces its fluid restriction, allowing an increasingly greater amountof fluid to exit. Alternately, as the volume of fluid in the flowchamber 1104 increases, the float 1130 b rises, thereby allowingincreased fluid to exit through the outlet 1104 b. This may correspondto a higher flow rate of urine, at which less sensitivity in flow ratemeasurement may be required. The outlet 1104 b also includes anelongated opening positioned above and connected to thetriangular-shaped opening. This elongated opening may mitigate overflowor backflow conditions, for example, by allowing for additional fluidrelease when the flow chamber 1104 approaches capacity. It will beappreciated that the shape and arrangement of the outlet 1104 b isdepicted for purposes of illustration. In other examples, other shapesand arrangements of outlets are possible to facilitate the variousfunctions of the voiding device 1100 described herein.

The voiding device 200 measures one or more parameters of a patient'surinary voiding. For example, the flow chamber 204 can collect urine andmeasure urine parameters by one or more sensors. In one example, thevoiding device 200 determines the date and time of a void, voidedvolume, average void flow rate, voiding time, flow time, maximum flowrate, and the time to maximum flow rate.

The I/O interface 258 provides communication to and from the voidingdevice 200 to exterior devices and/or the user. The I/O interface 258may include one or more input buttons, a communication interface (suchas Wi-Fi®, Ethernet, Bluetooth®, NFC, RFID, cellular, infrared or otheroptical communications, or the like), communication components (such asuniversal serial bus (USB) ports/cables), or the like. In variousexamples, the I/O interface 258 transmits sensor data from the voidingdevice 200 to a remote computing device, such as a remote server 112.The I/O interface may also transmit data to a healthcare provider device109, a report device 110, a third party device 103, a user mobile device108, or a charging station 114.

The one or more validation sensors 260 may be substantially any type ofelectronic device capable of measuring the orientation value of thevoiding device 200. For example, the one or more validation sensors 260may be an orientation sensor such as a gyroscope or an accelerometer formeasuring the orientation of the voiding device 200. Additionally oralternatively, the one or more validation sensors 260 may be acapacitive (or capacitance), or resistive sensor for proximitydetection. For example, a capacitance sensor in the handle may determinethat the handle is held in the user's hand and may measure the deviceproximity to the human body. In another example, the device processingelement 252 may detect the user's grip through a validation sensor 260,such as a capacitance sensor, and infer the orientation of the voidingdevice 200 from the user's grip.

The validation sensors 260 may cooperate to automatically power thedevice on/off. In various examples, both an accelerometer and acapacitive sensor are used to activate the voiding device 200automatically (e.g., the device is activated when the accelerometerdetects motion and the user's grasp is detected by the capacitivesensor.). For example, the voiding device 200 may provide power to anaccelerometer when the voiding device 200 is in an otherwise idle state.When the accelerometer detects motion, it may cause the proximity sensorto receive power, enabling the proximity sensor to detect the presenceof a user's touch. If both the accelerometer and the proximity sensordetect conditions consistent with an impending void, such as a user'sgrasp on the handle and motion consistent with orienting a device into aparticular position, the voiding device 200 may then power the deviceprocessing element 252, preparing the voiding device 200 to receive flowdata. In other instances, detection of a value over a particularthreshold or within a selected range by either the accelerometer or theproximity sensor may be sufficient to activate the voiding device 200.

The one or more validation sensors 260 may measure the orientation ofthe voiding device 200, and the orientation data may be stored in thememory 254. In various examples, the voiding device 200 automaticallyturns on depending on the orientation of the voiding device 200, e.g.,with a capacitive sensor. For example, when the voiding device 200 ispositioned in a proper orientation for use as detected by the one ormore validation sensors 260, the one or more device processing elements252 may supply power to the voiding device 200 via the battery 272,thereby turning on the voiding device 200 for use. Powering on thedevice when it is in the correct orientation may happen automatically ormay be facilitated via a power button. For example, the voiding device200 may include a power button 279 (see, e.g., FIGS. 2A and 2B) topermit the user to manually turn the voiding device 200 on or off.

In other examples of the voiding device 200, an LED light may illuminatewhen the device is in the correct, desired, or optimal position relativeto the patient's body. Additionally or alternatively, the voiding device200 may include a display, such as an LED display. The LED display maybe integrated with the handle of the voiding device 200 and coupled withthe one or more validation sensors 260 and/or other sensors. The displaymay indicate a current or instantaneous orientation of the voidingdevice 200, including a pitch and/or roll condition or value. Asdescribed herein, the voiding device 200 may have a target condition ortarget orientation that is associated with an optimal operation of oneor more components of the voiding device 200, such as the displacementsensor 222. In this regard, the display may indicate the currentorientation of the voiding device 200 relative to the target conditionor orientation. When the current orientation matches and/or is within anacceptable range of the target, the voiding device 200 may be in a statein which it receives a flow of a patient's urine.

FIG. 3B is a simplified block diagram of additional components within orassociated with a server 112. The server 112 may contain one or moreserver processing elements 152, a power source 156, memory 154, and oneor more I/O interfaces 158. Each element of the server 112 may beconnected via one or more system buses 166.

Referring to FIG. 3B, the one or more server processing elements 152 aresubstantially any type of electronic device capable of processing,receiving, and/or transmitting instructions. For example, the serverprocessing elements 152 may be a microprocessor or a microcontroller.Additionally, it should be noted that select components of the server112 may be controlled by a first server processing element 152 and othercomponents may be controlled by a second or subsequent server processingelement 152, where the first and second server processing elements 152may or may not be in communication with each other. Additionally oralternatively, select data processing steps or processes may beperformed by one server processing element 152 with other dataprocessing steps performed by different server processing elements 152,where the different server processing elements 152 may or may not be incommunication with each other. Additionally, some data processing stepsor processes may be performed by one or more device processing elements252 and others performed by one or more server processing elements 152,where the respective processing elements may or may not be incommunication with one another.

The one or more memory components 154 may store electronic data used bythe server processing element 152, as well as to store data collected bythe voiding devices 200, the user mobile devices 108, the healthcareprovider devices 109, the report devices 110, and/or the third partydevices 103, for example. The example memory devices 254 described forthe voiding devices 200 may also serve as example memory devices 154.The memory devices 154 may be the same types of devices as memory 254 ofthe voiding device 200, or they may be different.

The power source 156 provides power to select components of the server112. Depending on the particular application, the power source 156 maybe a power cord, alternating current to direct current rectifier,transformer, or any other element transmitting electrical power to theserver 112. The power source 156 may include a backup battery to keepthe server powered in the event of a power grid failure.

The I/O interface 158 provides communication to and from the server 112to exterior devices, and the network 102. The I/O interface 158 mayinclude a communication interface (such as Wi-Fi®, Ethernet, Bluetooth®,NFC, RFID, fiber optics, cellular, infrared or other opticalcommunications, or the like), communication components (such asuniversal serial bus (USB) ports/cables), human interface components(such as a keyboard, mouse, stylus, monitor, touch screen, microphone,speakers), or the like. In various examples, the I/O interface 158receives sensor data from the voiding device 200, recording it in memory154 for further processing by the server processing element 152. Forexample, the server processing element 152, may validate whether thedata are associated with a void, process the sensor data to calculateurine flow rate and total volume voided for each urinary event,reprocess the data, store the data, retrieve analyzed data, and/orgenerating reports. In other examples, summary flow rate calculationsare transmitted to the server. In another example, the I/O interface 158transmits raw data to a server 112, or another device. In anotherexample, the I/O interface transmits filtered data to a server 112, orother device.

Additionally, it should be noted that although various methods andoperations are described as being executed by the device processingelement 252 on the voiding device 200, some operations may be executedin full or in part on an external processing element, such as on theserver 112 with the server processing element 152, or other processingelements associated with the healthcare provider device 109, third partydevice 103, user mobile device 108, report device 110, or other devices.Discussions of a particular processing element are meant as illustrativeonly.

FIG. 4 discloses a flow chart for a method 400 for determiningparameters associated with a flow event detected by the voiding device200. The method may be executed while a flow event is occurring or afterthe voiding device 200 has detected that a flow event has occurred andtransmits the unanalyzed data to the server 112 or other device via thenetwork for processing. In some instances, the device processing element252 may perform some analysis on the data, while the server processingelement 152 performs other analysis on the data. In some instances, theactivation of the method 400 may be determined based on the voidingdevice 200 being “activated” or otherwise detecting a flow event isabout to occur, such as through a user turning the voiding device 200 toan active state, the proximity sensor detecting the grip of the user,and/or the fluid level sensor 262 detecting an increase in the fluidlevel of the voiding device 200.

The method may begin with operation 402 and the device processingelement 252 or server processing element 152 receives or records aninitial fluid level in flow chamber 204. In one example, the fluid levelcorresponds to an angular position ϕ of the float 230 of the voidingdevice 200. For example, the respective processing element receives thefloat 230 position as indicated by the angular position ϕ₁ when the flowchamber 204 is substantially empty of fluid, as illustrated in FIG. 2E.The float 230 may be at a lower limit position indicating that the flowchamber 204 is empty and this position is provided to the respectiveprocessing element. In another example, the float 230 position isdetected at an initial value before use, or is retrieved from the memory254 as a default initial value. In one example, the position of thefloat 230 is an angular displacement or position value ϕ received from adisplacement sensor 222, such a Hall effect sensor. In another example,the position of the float 230 is a linear displacement or position valuereceived from a displacement sensor 222. In another example, the fluidlevel corresponds to a capacitance value of a capacitive sensor.

Also in operation 402, the device processing element 252 or serverprocessing element 152 receives or records the initial position ororientation of the voiding device 200 in 3D space as detected by thevalidation sensor 260 indicating the initial pitch value, and optionallythe initial roll value, of voiding device 200. In one example, thevalidation sensor 260 indicates the voiding device 200 is pitched withinthe flow chamber 204 rotated downward relative to handle 202, about anaxis parallel to the pivot axis 232. In another example, the validationsensor 260 indicates the voiding device 200 is pitched with the flowchamber 204 rotated upward relative to handle 202, about an axisparallel to the pivot axis 232. In another example, the validationsensor 260 indicates the voiding device 200 is rolled asymmetricallyeither direction about an axis perpendicular to the pivot axis 232. Thevalidation sensor 260 may indicate the position of the voiding device200 in any combination of pitch and/or roll in any direction about anyaxis. The validation sensor 260 may also indicate the position of thevoiding device 200 relative to any three orthogonal axes, or relative toa plane and an axis orthogonal to that plane. The detected positions maybe when the voiding device 200 is activated or a short time windowsafter activation (e.g., 3-5 seconds) that gives time for a user to turnon the voiding device 200 and then begin to void. Alternatively, theinitial orientation positions may be pulled from memory corresponding toa typical position of the voiding device 200 during a void and dependingon the patient's gender. For example, male patients may have anorientation or pitch and/or roll set to a first value that correspondsto most instances of use. Similarly, female patients may have anorientation or pitch and/or roll value at first release that correspondsto most instances of use. The method 400 may retrieve these values uponactivation or may dynamically update the values based on current actualposition at activation or first flow.

In operation 404, simultaneously or after the initial float position hasbeen received and one or both of pitch and/or roll are determined, thedevice processing element 252 or server processing element 152 receivesa time stamp corresponding to initial activation or initially detectedflow through the voiding device 200. For example, the device processingelement 252 can receive time and/or date information from the clockforming a time stamp. In another example, a time stamp is an date and/ortime, e.g., “Oct. 8, 2018 6:51:00 PM.” The time stamp may be in anyformat, such as formatted for 12-hours and AM/PM information as above,or formatted for 24 hour information, such as, “Oct. 8, 2018 18:51:00.”In another example, the clock accrues elapsed time between flow events.For example, the clock includes a timer that resets to zero once a voidevent is validated (as discussed below with respect to FIGS. 6 A, 6B),and begins counting the elapsed time until a next validated void event.The clock may account for differences in time zones between a healthcareprovider and a patient. For example, the time stamp may be recorded inGreenwich Mean Time (“GMT”). Alternately, the memory 254 may store timezone information of the patient's location and adjust the time stampaccordingly. The clock may account for periodic variances in time, suchas the beginning or end of daylight savings time, and leap years. Forexample, if daylight savings time begins between void events, clockadjusts void event time accordingly. For example, if the voiding device200 records a void event on Saturday Mar. 9, 2018 at 9 PM, then daylightsavings time begins on Sunday Mar. 10, 2018 at 2 AM, and the voidingdevice 200 detects another void event on Sunday Mar. 10, 2018 at 6 AM,the clock adjusts the time between void events to be eight hours ratherthan nine hours as the time stamps would indicate absent informationabout daylight savings time. In other examples, the clock may record atime interval between detected first flow or activation and the end offlow or deactivation e.g., 20 seconds.

The method may proceed to operation 406 and the device processingelement 252 or server processing element 152 monitors the fluid level inflow chamber 204 via fluid level sensor 262 over time by periodicallyreceiving output from the fluid level sensor 262 over a series ofsampling intervals. The device respective processing element alsomonitors the orientation of the voiding device 200 over time the byperiodically receiving output from the validation sensor 260, such asplurality of orientation values. In one example, the device processingelement 252 executes instructions to receive electronic signals with asampling rate of 1 sample per second, or 1-Hz. In this example, thedevice processing element 252 reads analog electrical signals from thefluid level sensor 262 and/or the validation sensor 260, and convertsthose analog signals to digital signals through a digital-to-analogconverter (DAC) circuit, thereby generating a plurality of fluid levelsensor values and/or a plurality of validation sensor or orientationvalues. The DAC circuit has a certain digital resolution that it uses todivide the analog signal into discrete digital values of precision. Forexample, the DAC may have a digital resolution of 12-bits, where the DACdivides the analog signal into 2¹² or 4,096 discrete pieces of digitalinformation. The DAC may have lower or higher resolutions such as 8-bit,10-bit, 16-bit, 32-bit, or other values, for example. Additionally, theDAC may have lower or higher sampling frequencies defining the number ofsampling intervals per over a given time period. For example, the DACmay have sampling frequencies such as 0.1-Hz, 10-Hz, 100-Hz, definingone sampling interval every ten seconds, ten sampling intervals persecond, or 100 sampling intervals per second, respectively. The samplingfrequency may be varied based on desired sensitivity, expected flowrates, or the like. The device processing element 252 reads these piecesof digital information to monitor the position of the displacementsensor 222, and may further process or refine the digital information,storing and retrieving some or all of it in the memory 254. In anotherexample, the device processing element 252 simply records inputs asreceived directly or indirectly from the sensors in memory 254.

Continuing operation 406, the device processing element 252 or serverprocessing element 152 monitors a number of parameters about the fluidlevel in flow chamber 204, to determine a number of different outputs.In one example, the device processing element 252 monitors the float 230position. In one example, the device processing element 252 monitors thefloat 230 angular position ϕ over time and records that it initiallyincreases, as fluid flow increases. In one example, as illustrated inFIG. 2E, the float 230 begins at a lower position indicated by ϕ₁, withthe float 230 resting on the inner surface of the bottom wall 218 of theflow chamber 204. As fluid flows into the flow chamber 204, the float230 angular position ϕ may move to a higher value, for example, ϕ₂, asillustrated in FIG. 2F. As illustrated for example, in FIG. 2G, thefloat 230 angular position may reach a peak value ϕ₃ as fluid flowreaches a peak value. During a flow event, the angular position ϕ of thefloat 230 may move up or down, as variations in flow rate into or out ofthe flow chamber 204 occur. The float 230 angular position ϕ maydecrease over time as fluid flow decreases, eventually returningsubstantially to its initial position ϕ₁. These variations are capturedby the device processing element 252 at the desired intervals over theflow event timeframe and are optionally stored in memory 254 ortransferred to another device, for example to server processing element152. In another example, the device processing element 252 monitors acapacitance value of a capacitance level sensor corresponding to thefluid level in the flow chamber 204.

Also in operation 406 the device processing element 252 or serverprocessing element 152 monitors the orientation of the voiding device200 by receiving signals from validation sensor 260. The validationsensor 260 monitors the pitch and/or roll of the voiding device 200 in3D space. The orientation of the voiding device 200 in 3D space mayaffect the outflow rate from the outlet 204 b. For example, if thevoiding device 200 were pitched with the outlet 204 b at a positionsubstantially downward relative to the handle 202, the outflow rate offluid may be increased relative to a position where the voiding device200 was held in an orientation closer to horizontal. For example, thevalidation sensor 260 indicates a number of degrees from horizontal thatthe voiding device 200 is pitched. The validation sensor 260 may alsoindicate a direction of the pitch, such as downward or upward, where thedirection is defined relative to the handle or other predetermined pointon the device 200. In another example, the validation sensor 260indicates a number of degrees of roll from horizontal, and a direction,e.g., 20 degrees left. In another example, the voiding device 200 issymmetric about an axis perpendicular to pivot axis 232 and thevalidation sensor 260 indicates a roll without a direction. In anotherexample, the validation sensor 260 indicates a number of degrees and adirection that the voiding device 200 is offset relative to each ofthree orthogonal axes, e.g., 10 degrees from the z-axis, −20 degreesfrom the y-axis, and 5 degrees from the x-axis.

The method may proceed to operation 408 and the device processingelement 252 or server processing element 152 receives information thatthe fluid level in flow chamber 204 is at a limit position. For example,the fluid level sensor 262 may indicate that the flow chamber 204 isempty. In one example, the device processing element 252 receivesinformation that the float 230 is at a limit position indicating thatcorresponding fluid level is at a limit position. For example, asillustrated in FIG. 2E, the float 230 may be at rest against the innersurface of the bottom wall 218 of voiding device 200, as measured byangular position ϕ₁. In other examples as illustrated in FIG. 2F, thefloat 230 may be at other positions, such as angular position ϕ₂, asillustrated in FIG. 2F. The movement of the fluid level from a lowerlimit position ϕ₁, and then later returning to substantially the samelower limit position ϕ₁ may be used by device processing element 252 todetect the beginning and end of a flow event. For example, as fluid flowinto the flow chamber 204 decreases, the float 230 may move to lowerpositions as fluid continues to flow out of the outlet 204 b. The float230 may also move to higher positions over the course of a void, due tochanges in flow rate, the position of the voiding device 200, shaking,or other vibrations. Over time, the position of the fluid level shouldtrend downward as flow diminishes and ceases. Eventually, as fluid flowstops and the remaining fluid within the flow chamber 204 exits, thefluid level reaches the lower limit position indicating the end of aflow event. For example, the float 230 may reach the end of its travelpath, such as a mechanical stop. One example of a mechanical stop is thefloat 230 contacting the inner surface of the bottom wall 218 of theflow chamber 204. Another example of a mechanical stop may be mechanicallimits built into one or both of the axles 236 a, 236 b. In anotherexample, a lower limit position of the float 230 may be an electrical orsensor limit. For example, displacement sensor 222 senses rotaryposition within certain limits, beyond which it will sense a maximum orminimum value of rotation, as appropriate. The lower limit may bedetectable by the validation sensor 260, and/or separate limit sensorsthat output a signal when the float 230 hits the limit, e.g., the arms234 a, 234 b rest against a mechanical stop including a proximitysensor. At the flow event time, an end time stamp may be recorded,marking the end of the interval. In another example, the capacitancevalue of a of a capacitance level sensor indicates a fluid level limitposition in the flow chamber 204.

Once the fluid level reaches the lower limit position, the flow event ispresumed to be over, i.e., there is no fluid remaining in thecompartment. There may be a wait time after the fluid level reaches itslower limit to capture any secondary flows that may occur. Once the flowevents are assumed to be over, the method may proceed to operation 410and a processing element determines flow data corresponding to the flowevent. In one example, the device processing element 252 of the voidingdevice 200 transmits un-analyzed fluid level and voiding device 200position data to the server 112 via a cellular network. The serverprocessing element 152 analyzes the fluid level in the flow chamber 204over the flow interval time. In one example, the device processingelement 252 or a server processing element 152 analyzes the angularposition ϕ of the float 230 (e.g., ϕ₁, ϕ₂, ϕ₃, illustrated, for example,in FIGS. 2E-2G and positions in-between) and the orientation (e.g.,pitch and/or roll) of the voiding device 200 using validation sensor 260over the flow event time interval. The server processing element 152uses the time data, angular position data, and position data in 3D spaceto determine input flow rates and/or accumulated flow volumes. Forexample using predetermined characteristics of the voiding device 200relative to float angular position ϕ and voiding device 200 orientationand the detected data, the flow rates can be determined. Thepredetermined characteristics may be stored either within memory 254 ofthe voiding device 200, or in memory on a server 112 or other device.

In one example, the device processing element 252 or the serverprocessing element 152 uses fluid level data, such as fluid sensorpositions, and/or orientation values to interpolate or translate inputflow rates from predetermined characteristics in the form of a lookuptable or other relational structure. In one example, the deviceprocessing element 252 or the server processing element 152 uses floatangular position ϕ and voiding device 200 orientation (e.g., pitchand/or roll) to interpolate input flow rates from predeterminedcharacteristics in the form of a lookup table. The voiding device 200has an outlet 204 b that may be shaped to have lower outlet flows atlower corresponding inlet flows, to increase the sensitivity of the flowmeasurements. The outlet 204 b may also have higher outlet flows atcorresponding higher inlet flows to prevent urine from overflowing theflow chamber 204. The voiding device flow chamber 204 and outlet 204 bshapes may also be different between the male and female devices toincrease sensitivity in target urine flow ranges. That is, the flowchamber and outlet may be configured to optimize collection precision,orientation, and/or comfort for the user depending on the user's anatomyand common void positions. This helps to ensure that the user cancomfortably handle the voiding device during void events, while alsoensuring that the fluid is properly captured and accurately measuredduring the voiding events.

The voiding device 200 may have an outlet 204 b that has differentoutlet flow characteristics at different voiding device 200orientations, e.g., at different pitch, roll, and/or fluid level sensor262 positions, which allow determination of flow properties, (e.g.,rate, volume, time, duration, peak, onset and/or end of flow) bydetecting changes of these characteristics. Tables 1A, 1B, and 1C belowillustrate exemplary relationships between these values.

TABLE 1A Actual Predetermined roll Predetermined Predetermined FloatRoll deg. deg. Roll deg. Angular Position φ: 10° 10 12 20 PredeterminedPitch deg. 20 12 17 Actual Pitch deg. 30 18.5 19.7 24.5 PredeterminedPitch deg. 40 25 32 Outlet flows mL/sec

TABLE 1B Actual Predetermined roll Predetermined Predetermined FloatRoll deg. deg. Roll deg. Angular Position φ: 20° 10 12 20 PredeterminedPitch deg. 20 17 23 Actual Pitch deg. 30 26 27.6 34 Predetermined Pitchdeg. 40 35 45 Outlet flows mL/sec

TABLE 1C Predetermined Float Outlet flows Angular Position φ mL/secPredetermined Float 10 19.7 Angular Position φ Actual Float 18 23.65Angular Position φ Predetermined Float 20 27.6 Angular Position φ

With reference to Tables 1A, 1B, and 1C above, in one example, at aparticular moment or snapshot in time (such as a particular samplinginterval) during a flow event, the voiding device 200 has a pitch of 30degrees from horizontal on an axis parallel to pivot axis 232, with theflow chamber 204 angled down relative to the handle 202, has a roll of12 degrees from horizontal on an axis perpendicular to pivot axis 232,and the float 230 angular position ϕ is 18°. Continuing the example, theserver 112 memory 154 contains the following predetermined output flowrate characteristics at a float 230 angular position of 10 degrees. SeeTable 1A. The memory contains an outlet flow rate of 12 mL/seccorresponding to a pitch of 20 degrees, and a roll of 10 degrees. Thememory 154 contains predetermined output flow rate of 25 mL/sec at apitch of 40 degrees, a roll of 10 degrees, a predetermined output flowrate of 17 mL/sec at a pitch of 20 degrees and a roll of 20 degrees, anda predetermined output flow rate of 32 mL/sec at a pitch of 40 degreesand a roll of 20 degrees. As illustrated, the memory contains thefollowing predetermined output flow rate characteristics at a float 230angular position of 20 degrees, an outlet flow rate of 17 mL/seccorresponding to a pitch of 20 degrees, and a roll of 10 degrees, andmemory 154 contains predetermined output flow rate of 35 mL/sec at apitch of 40 degrees, a roll of 10 degrees. Further, the memory 154contains a predetermined output flow rate of 23 mL/sec at a pitch of 20degrees and a roll of 20 degrees and contains a predetermined outputflow rate of 45 mL/sec at a pitch of 40 degrees and a roll of 20degrees.

The server processing element 152 or the device processing element 252uses interpolation, for example bi-linear interpolation, to determinethe outlet flow rate of 19.7 at the conditions in Table 1A, and 27.6mL/sec at the conditions of Table 1B. The respective processing elementthen interpolates between the outlet flow values at predetermined floatangular positions ϕ of 10 and 20 degrees from tables 1A and 1B,respectively, for an actual float position ϕ of 18 degrees. Therespective processing element determines the outlet flow rate of 23.65mL/sec. See Table 1C. The respective processing element may use othertypes of interpolation, e.g., linear, cubic, bi-cubic, one dimensionnearest neighbor or two dimension nearest neighbor. In various examples,the server processing element 152 determines outlet flows using one ofthe pitch, roll or fluid level sensor 262 position inputs; or any two ofthe preceding inputs in any combination.

The server processing element 152, or the device processing element 252then uses the float 230 angular position ϕ and the interpolated outletflow rate to determine the inlet flow rate. For example, the inlet flowrate is determined as the output flow rate plus any change in retainedvolume in the flow chamber 204 since the last sampling interval. If thefluid level sensor 262 rises from one sampling interval to the next,then there is more fluid volume retained in the flow chamber 204 in thecurrent sampling relative to the previous sample, and the input flowrate is correspondingly higher than the outlet flow rate. Likewise, ifthe fluid level sensor 262 falls in the current sampling intervalrelative to the previous sampling interval, then the outlet flow rate ishigher than the inlet flow rate. This retained volume is determined fromlookup tables, using similar methods and inputs (e.g., pitch, roll, andfluid level sensor 262 position) as with the outlet flow rates asillustrated e.g., in Tables 1A, 1B, and 1C.

In another example, the predetermined characteristics take the form of amathematical relationship with float 230 angular position ϕ, pitch, andoptionally roll, as inputs and input flow rate as an output. In oneexample, the server processing element 152 determines urine flow rate byanalyzing the outflow rate with float 230 angular position ϕ data,and/or voiding device 200 orientation data. In particular, the serverprocessing element 152 (or device processing element 252) uses the float230 position over the detected time period in light of the known exitrate of the flow chamber 204 to determine the rate of flow into the flowchamber 204, e.g., from the user. The above is meant as illustrativeonly and the flow rate input into the voiding device 200 can bedetermined in other manners.

The method may proceed to operation 412 and the server processingelement 152 or the device processing element 252 determines a totalfluid flow volume for the event. For example, the server processingelement 152 may numerically integrate a fluid input signal over time asdetermined from the fluid level data and voiding device 200 positiondata, such as determined in operation 410. In one example of a method ofnumerically integrating urine flow rate, the server processing element152 uses a left end-point rectangular approximation to obtain anestimate of accumulated fluid flow over time. The respective processingelement may use flow rate data, such as data determined in operation410, to estimate an accumulated amount of fluid over a time step, andstore the result in the memory 254. For example, if the deviceprocessing element 252, or the server processing element 152, samplesfluid flow rate at 0.1 second sampling intervals, the accumulated volumein any particular sampling interval may be determined by multiplying thesampled value of flow rate by the time step (e.g., 0.1 s). Then forinstance, if the device processing element 252, or the server processingelement 152, samples fluid flow rate at 5.0 seconds since the onset offluid flow, and the value of the fluid flow rate may be 7 millilitersper sec (mL/s). The respective processing element would multiply 7 mL/sby 0.1 seconds to arrive at an accumulated amount of fluid over the timestep from 5.0 seconds to 5.1 seconds of 0.7 mL. The respectiveprocessing element would then add 0.7 mL to accumulated volumes of fluidfrom previous time steps, and store the result in the memory 254. Inother examples, the respective processing element may use left end,right end, trapezoidal, midpoint, Simpson's, parabolic, or otherapproximations to determine an accumulated urine volume. Operation 412may result in a vector of data points of accumulated fluid volume, andmay also result in a corresponding vector of associated times. Thedevice processing element 252 may store these vectors in the memory 254,or the server processing element 152 may store these vectors in thememory 154. Other types of calculations can be done as well that intakecharacteristics of the voiding device 200 and flow rate data todetermine accumulated flow volume.

The method may proceed to operation 414 and the server processingelement 152 or the device processing element 252 stores the flow eventdata in memory storage, either on the device itself in memory 254, onthe server 112 in memory 154, or the like. In various examples, the flowevent data are raw data or filtered data. In one example, the deviceprocessing element 252 transmits flow event data to the server 112 viathe network 102, such as a cellular network and the server 112 storesthe flow event data in memory on the server 112. Alternately, the deviceprocessing element 252 transmits flow event data to the healthcareprovider device 109, the report device 110, the third party device 103,or any combination of the above. Alternately, the device processingelement 252 of the voiding device 200 transmits the flow event data tothe server 112 via network 102, which may be a private network such as acellular network, a public network such as the internet, or acombination.

In many instances, the voiding device 200 may detect flow events that donot correspond to actual voids, but instead to the user rinsing orwashing the voiding device 200. FIG. 5 is a flow chart illustrating amethod 500 for validating flow event data as being associated with avoid event. By validating data as being connected to an actual voidevent, rather than another event (e.g., user washing the voiding device200, inadvertent sensor detection, etc.), the system can avoid analyzingand transferring irrelevant data, helping to increase accuracy, as wellas efficiency of the device. For example, the device processing element252 may analyze one or more validation characteristics detected by thevarious validation sensors 260 within the voiding devices 200. Inparticular, the server processing element 152 or the device processingelement 252 may analyze validation characteristics such as accelerationof the voiding device during the flow event; the orientation of thevoiding device during the flow event; the orientation of a user hand onthe voiding device during the flow event; the temperature of the fluidflowing through the voiding device during the flow event; or the totalvolume of the fluid flowing through the voiding device during the flowevent. In particular the device processing element 252 can validatedetected flow event data to determine whether flow event data areassociated with a void event, or some other type of event, such as forinstance washing the voiding device 200, or accidentally dropping it ina toilet.

The device processing element 252 may execute method 500 to determinethat flow event data are potentially valid void data. The serverprocessing element 152, with its greater processing power, may receivevalidated void data and execute method 500 again on the data withdifferent thresholds, or analyses to double check, or more accuratelydetermine, the validity of the data. Alternately, operations or parts ofoperations of method 500 may be performed on the device processingelement 252 and others performed on the server processing element 152,or other processing elements associated with the healthcare providerdevice 109, third party device 103, user mobile device 108, or reportdevice 110. The method 500 may be executed while a flow event isoccurring or after the voiding device 200 has detected that a flow eventhas occurred and transmits the data to an on-board processor foranalysis and/or filtering or to a server 112 or other device via thenetwork 102.

The method may begin in operation 502 and the server processing element152 or device processing element 252 receives flow event data, such asthe data detected in method 400 and/or from a storage location, (e.g.,memory 154 on the server, the healthcare provider device 109, the reportdevice 110, the user mobile device 108, or the third party device 103)from a memory 254 location on the voiding device 200 or via the network102. In another example, the server processing element 152 receivesun-analyzed flow event data from the voiding device 200 via the network102. In another example, the processing element corresponds to thehealthcare provider device 109 and receives flow event data eitherdirectly from the voiding device 200 or indirectly via network 102. Inanother example, the processing element is within a report device 110and receives flow event data directly from a voiding device 200 orindirectly via network 102. In yet another example, the processingelement is within a third party device 103 and receives flow event datafrom the voiding device 200 directly or indirectly via network 102.

After receiving flow event data, the server processing element 152 ordevice processing element 252 may then analyze the data with respect tovarious sensors, validation characteristics, and characteristicthresholds to determine if the data is valid. The method may proceed tooperation 504 and the respective processing element determines whetherthe float 230 orientation and/or the orientation of the voiding device200 itself are correct for a detected flow event. The orientation may bedetected based on a position of the displacement sensor 222, as well asa 3D position/orientation of the voiding device 200. For example, if thefloat 230 was at an abnormal position, such as at its full upper limit,when flow through outlet 204 b was detected, the respective processingelement may determine a rinsing event has occurred. As another example,if the validation sensor 260 detects high acceleration values over theevent time, the respective processing element may determine that a userwas tapping the voiding device 200, such as during a rinse event. Forexample, the respective processing element may determine that the float230 reached an upper limit position during a flow event, therebyclipping flow event data. This condition could be indicative of a highvolume flow, as from a faucet, while a user rinses the voiding device200.

In another example, the float 230 may be detected at an intermediateposition after the flow event was over, indicating that the flow chamber204 contains some fluid, or possibly that the float 230 was stuck. Inone example, the respective processing element receives the float 230position over time to determine if the float 230 was steady, e.g.,stable, or not shaking or moving erratically. For example, if the float230 was at a lower limit position or some other initial startingposition, and was steadily at or near that position for a pre-determinedperiod of time, the respective processing element may determine that thevoiding device 200 was stable enough to take accurate measurements. Inanother example, if the initial position of the float 230 varieserratically over time, the respective processing element may determinethat the voiding device 200 was not stable enough to take accuratereadings. In one example, the respective processing element monitors thefloat 230 position to determine whether the float 230 position containssignal noise, or other variations not associated with a void event. Inone example, the device processing element 252 (or the server processingelement 152, or another device) detects the orientation of the voidingdevice 200 via input from the validation sensor 260 and/or the fluidlevel sensor 262 and compares the voiding device 200 position to aurinary event position to determine that the detected orientation isvalid. The urinary event position may be predetermined and may be storedin memory 254 on the voiding device 200, or in the memory of anotherdevice.

The urinary event position may be different for various patientsdepending on various factors. For example the urinary event position maydepend on the patient's gender (e.g., the urinary event positioncorresponds to a sitting position for a female patient, or a standing orsitting position for a male patient). In another example, the urinaryevent position corresponds to different patient positions if the patientis not ambulatory, uses a wheel chair or other assistive device. FIG. 12illustrates output from a validation sensor 260, showing changes inacceleration of the voiding device 200, along with different events,such as setting the voiding device 200 down, voiding, and rinsing. Largechanges in acceleration may be indicative of unsteady conditions wherethe voiding device 200 will be unable to take accurate readings. Thevarious sensors and/or thresholds may be analyzed simultaneously,independently, or serially depending on the desired processing speed,robustness of the voiding device 200. As such, the discussion of thebelow operations should be understood to be executed in any order ortiming, and various operations may be omitted or skipped as desired.

Additionally the server processing element 152 or device processingelement 252 may analyze an orientation output to determine whether thevoiding device 200 was in a proper position to collect urinary eventdata. For example, if the validation sensor 260 indicates the voidingdevice 200 was in a position other than substantially right side up(e.g., upside down with flow chamber 204 opening oriented toward theground, sideways, tilted too far vertically up or down on an axisparallel to the pivot axis 232, and/or tilted too far to the left orright with respect to an axis perpendicular to the pivot axis 232), therespective processing element determines that the voiding device 200 wasnot in a proper position to collect urinary event data. If however, thevalidation sensor 260 values over time indicate the voiding device 200was in a proper position to receive urinary event data, method 500 mayproceed to operation 506. An example of output from the validationsensor 260 is illustrated in FIG. 12. FIG. 12 shows acceleration changedata 1200, such as the number of degrees the voiding device 200 was fromupright, for different activities, such as setting down 1202, voiding1204, and rinsing 1206. FIG. 14 illustrates a superposition ofacceleration change, as in FIG. 12, positioning error as in FIG. 13, anddifferent events, showing for example how voiding and rinsing can bedifferentiated from one another.

FIGS. 12-14 illustrate various threshold values for different events.For example, FIG. 12 indicates low changes in acceleration when thevoiding device 200 was set down, region 1202 or during a void, region1204, and high values of acceleration change when rinsing 1206. FIG. 13shows positioning error data 1300. Like FIG. 12, FIG. 13 showsunchanging positioning error data 1300 at about 120 degrees when thevoiding device 200 was set down 1302, and a positioning error of about 0degrees while voiding 1304, and erratic swings in positioning errorwhile rinsing 1306. FIG. 14 shows the combination 1600 of positioningerror data 1300 and acceleration change data 1200, as used todifferentiate between setting the voiding device 200 down 1602, voidevents 1604 and rinsing 1606. For example, the respective processingelement may determine that a void is happening when both the motion ofthe device is below a threshold, as in region 1204 FIG. 12, and when thepositioning error is within some threshold as in region 1304, FIG. 13.The device processing element 252 and the server processing element 152may use different thresholds or criteria for determining the validity ofa void event. The respective processing element may use accelerationchange data 1200, positioning error data 1300, alone or in anycombination to discriminate between different types of events. However,by combining acceleration change data 1200 and positioning error data1300 into combined data 1600, the respective processing element may beable to more accurately discriminate between different types of eventsthan with a single data set.

In operation 506, the server processing element 152 or device processingelement 252 determines whether fluid flow data associated with a flowevent are within certain boundaries for urine flow by comparing the flowdata to a variety of thresholds. The thresholds may either bepredetermined; may be learned by the respective processing element frompast history of a given patient; learned from typical data of patientswith similar age, gender, ethnicity, height weight, and medicalcondition or history; or may be a combination of such thresholds. Forexample, the respective processing element may compare the detectedfluid flow rate to a characteristic urinary event flow rate. Thecharacteristic urinary event flow rate may be determined based on valuestypical for patients of similar demographics (e.g., gender, age, orethnicity) as the current patient, or may be learned for a particularpatient over time. For example, fluid flow rates may be too high or toolow relative to characteristic, typical, or even possible urine flowthresholds for human beings. In another example, total accumulated fluidflow volumes may be too high or too low relative to characteristic,typical or even possible urine volume thresholds for human beings. Forexample, a total accumulated fluid volume of 3 gallons of urine was toohigh for any single void event for any human. In another example, peakflow rates may be too high or too low relative to typical or evenpossible values for human beings. For example, a peak fluid flow rate of100 gallons of urine per minute was too high of a peak flow rate for anyhuman. In another example, the duration of a flow event may be too long,e.g., 5 minutes. In other examples, any of these preceding thresholdsmay be compared to typical values for populations of which the patientwas a member. For example, if the patient was a 65 year old male ofAsian descent with a history of hypertension and smoking, the respectiveprocessing element compares flow values to typical urine flow values forpersons of similar characteristics.

In operation 508 the server processing element 152 or device processingelement 252 determines whether the detected fluid temperature in theflow chamber 204 associated with a flow event was too high or too lowrelative to threshold temperature values for urine. Operation 508 may beoptional. For example, the respective processing element may compare thedetected temperature to a characteristic urinary temperature or atemperature corresponding to a void, such as a gradual increase overtime that stabilizes to body temperature. The detected fluid temperaturemay be determined by a sensor in contact with the fluid in the flowchamber 204, or it may be inferred from a temperature sensor elsewherein the voiding device 200 not in contact with the fluid directly, e.g.,a temperature sensor within the handle 202. For example, if eitherprocessing element determines, from a temperature sensor, that the fluidin the flow chamber 204 was above 50° C., the respective processingelement will determine that this temperature was too high for humanfluid output and the fluid was not urine from a patient, but due torinsing the voiding device 200. In another example, either processingelement compares fluid temperature in flow chamber 204 to typical bodytemperatures of about 37° C., and for deviations far above or below thattypical temperature will determine that the fluid was not urine. Thetemperature value may be between a small window, validating thetemperature only if not too cold and not too warm. The range may bewithin 10-15 degrees C., as human urine typically falls within expectedtemperature ranges. In another example, fluid temperature data arerecorded from a from a temperature sensor in proximity to the urinestream, but not in fluid contact with the urine stream. For example, themagnetic float sensor 262 may have temperature sensor within it. Suchtemperature data may trend toward body temperature (from ambient) overthe course of a flow event. A processing element may use that data as asignal that the event is truly a urinary or void event.

In operation 510 the server processing element 152 or device processingelement 252 determines whether fluid flow data associated with a flowevent are within certain boundaries for urine, by comparing flow data toother thresholds. Operation 510 may be optional. In one example, therespective processing element compares the electrical conductivity offluid in the flow chamber 204 to threshold values for urine. Forexample, if the fluid has a low electrical conductivity, it may bedistilled or de-ionized water. In another example, if the fluid has avery high electrical conductivity, it may be salt water. In anotherexample, the respective processing element compares the opacity of fluidwithin the flow chamber 204 to threshold values for urine.

If the server processing element 152 or device processing element 252determines in one or more of operations 504, 506, 508, or 510 that theflow data associated with a flow event are not void data, the method mayproceed to operation 514 where the respective processing elementdiscards the flow event data.

If however, the server processing element 152 or device processingelement 252 determines in one or more of operations 504, 506, 508, or510 that the flow data are void data, (i.e., corresponding to a humanvoid event) the method may proceed to operation 512 where the respectiveprocessing element determines that flow event data are valid void dataand determines a valid void profile 600. The method may end in operation616

Once flow event data has been validated, the processing element (eitherin the voiding device 200, server 112, user mobile device 108,healthcare provider device 109, report device 110, or third party device103) generates a void profile. For example, the method 400 of FIG. 4 maybe applied to generate the void profile and determine the associatedcharacteristics. FIGS. 6A-6B illustrate an example of a void profile600. The respective processing element may use the inlet flow of urineover time, and total urine volume accumulated over time, to develop avoid profile. An example of a void profile may be seen in FIGS. 6A and6B. FIG. 6A illustrates an example of urine flow over time. FIG. 6Billustrates an example of accumulated urine flow over time. Asillustrated in FIG. 6A, the void profile 600 may have points and regionsthat may be detected by the respective processing element. For example apoint may be a single point in time. A region may span between two ormore points. The void profile is generated by the respective processingelement by plotting the determined flow rate over the flow event timeframe. Additionally, determined volume vs. time relationships may beplotted. The time stamps detected in method 400 along with thedetermined value can be used.

For example, the server processing element 152 or device processingelement 252 may detect an onset of urination 601, for instance bydetecting a change in a signal from a sensor. In one example, the deviceprocessing element 252 detects in increase of an output of the fluidlevel sensor 262, such as the float 230 displacement by way of the Halleffect sensor 222. In another example, the device processing element 252detects a change in a conductivity sensor, for instance detecting anincrease in conductivity between a pair of electrodes, consistent withthe presence of an electrically conductive fluid such as urine. Inanother example, the device processing element 252 detects a change inan opacity sensor, for instance detecting an increase in opacity ordecrease in transmitted light between an optical transmitter and anoptical receiver, consistent with the presence of a liquid. In anotherexample, the device processing element 252 detects a change in thelocation of an incident light beam on an optical detector caused by adifference between the index of refraction between air and water, urineor some other liquid. For example, an optical transmitter may be a lightsource, such as a light emitting diode, and an optical receiver may be alight sensor such as a phototransistor or cadmium-sulfide photodetectoror other photo detector.

Generally, void profile 600 may further have a region of increasingurine flow. For example, the void profile 600 may have a region 602where urine flow rate increases from the point of onset 601 to a maximumvalue at point 603. At point 603, urine flow may decrease, but isvariable depending on the particular patient.

The void profile 600 may further have a region of slowly decreasingurine flow. For example, void profile 600 may have a region 604 whereurine flow rate decreases slightly over time from the maximum point 603or where urine flow rate remains substantially uniform over time. Urineflow rate may continue in region 604 to point 605, the beginning of theterminal region of urination. At point 605, the time rate of change ofthe flow rate of urine may begin to decrease in region 606, relative toregion 604. In region 606, the flow rate of urine may decrease to apoint 607 where urine flow rate substantially ceases. Following thepoint of cessation of urination, e.g., at point 607, the void profile600 may include an additional region 608. Region 608 may represent adelay while the voiding device 200 waits to determine if urination maybegin again. Some urinary health problems involve halting urination,where urine flow starts and stops multiple times with in a single voidevent. Region 608 in void profile 600 will help the voiding device 200capture urination data consistent with such problems. As described withrespect to operation 412 of method 400, the server processing element152 or the device processing element 252 may numerically integrate theflow rate of urine over time to develop an accumulated urine profile,for example profile 620.

FIG. 7 is a flowchart illustrating a method 700 that determinesparameters associated with a void profile 600. The method may beexecuted after a flow event has been validated as a valid void event bythe processing element, on either the server 112, the voiding device200, the user mobile device 108, or the like. In one example, the deviceprocessing element 252 sends valid or filtered void data, such asvalidated by method 500, to the server 112 via the network 102. Theserver processing element 152 then executes method 700 to determineparameters associated with a void profile 600. Alternately, in anotherexample, the device processing element 252 of the voiding device 200executes portions of method 700, and the server processing element 152executes others. Various operations of method 700 may be executed byprocessing elements on any combination of devices, any order, includingthe voiding device 200, the healthcare provider device 109, the server112, the report device 110, the user mobile device 108, and/or the thirdparty device 103.

The method may begin with operation 702 when the server processingelement 152 or device processing element 252 receives validated voiddata. The validated void data correspond to data collected by thevoiding device 200 (e.g., fluid level data, pitch and/or roll) that hasbeen validated via method 500 and corresponding to a void event, ratherthan another type of flow event. The validated void data may be receivedfrom any of the voiding device 200, the sever 112, healthcare providerdevice 109, the third party device 103, the user mobile device 108, thereport device 110, or even another device. Validated void data may bereceived by the server processing element 152 either directly from oneor more of the other devices, or it may be received via network 102. Inone example, validated void data are a vector of data points of urineflow rates, and a corresponding vector of associated times stored by theserver processing element 152 in the memory 154. The server processingelement 152 may repetitively retrieve and store whole sets of void dataor individual data points at various addresses within the memory 154. Inanother example, void data also include a vector of data points ofaccumulated urine volume, also associated with the corresponding vectorof associated times. A truncated example of void data for a particularvoid event are represented by Table 2. Table 2 is not an example of anentire void profile, and is included as a tool to illustrate theoperations of method 700. Data points occupy a position within the datavector. A data vector has a beginning at position 1 and an end.

TABLE 2 Time Urine Flow Accumulated Urine Position (s) Rate (mL/sec)Volume (mL) 1 1 0 0 2 2 1 2 3 3 1 5 4 4 2 13 5 5 1.5 20.5 6 6 1 26.5 7 70 26.5 8 8 0.002 26.516

It should be noted that although the operations of method 700 are shownin a particular order they can be executed in parallel, separately, andin any order as desired. In operation 704 the server processing element152 or device processing element 252 determines peak urine flow rate.For example, a peak urine flow rate such as point 603 of FIG. 5. In oneexample, the respective processing element determines peak urine flowrate by stepping through data points of the validated void data vectorfrom beginning to end, two at a time and comparing them to determinewhich is larger. If the larger value is first in the vector, thepositions of the two data points are left undisturbed. If, however, thesmaller value is first, the positions of the two data points areswapped. This process continues through the vector and is then repeateduntil the vector of data points is in descending order, with the largestvalue first. In another example, the positions of the times associatedwith the data points are swapped whenever the data points themselves areswapped. This example results in a vector of data points sorted indescending order, and time vector containing associated times sortedaccording to the corresponding data points.

In another example, the server processing element 152 steps through datapoints of a validated void data vector one at a time. The serverprocessing element 152 copies the first data point to a buffer locationin the memory 154. The value in the buffer location may be called abuffered flow rate value. The server processing element 152 may alsostore the time value associated with the buffered value in a secondbuffer location in the memory 154. The value in the second bufferlocation may be called a buffered time value. The server processingelement 152 may then proceed to step through the second and subsequentvalues in the validated void data vector. The server processing element152 compares the second value in the validated void data vector to thebuffered flow rate value. If the second value in the validated void datavector is larger than buffered flow rate value, the server processingelement 152 copies the second value to the buffer in the memory 154,overwriting the buffered flow rate value. The server processing element152 may also store the time value associated with the new buffered flowrate value in the second buffer location. If, however the second valueis equal to or smaller than the buffered value, the buffered flow ratevalue and/or buffered time value are left unchanged. The serverprocessing element 152 repeats this process through the validated voiddata vector of flow rate data. The operation then concludes with theserver processing element 152 taking the current buffered value anddetermining it to be the peak urine flow rate. In the example of Table2, the server processing element 152 would determine the peak value ofurine flow rate as 2 mL/sec, at point 4. Other magnitude comparisons canbe done as well, using various methodologies, the server processingelement 152 analyzes the data to determine the peak.

In operation 708 the server processing element 152 or device processingelement 252 determines accumulated void volume. In one example, thevalidated void data contains a vector of accumulated urine flow volumes(e.g., such as determined in operation 412 of method 400 and validatedby method 500), and the server processing element 152 performs the stepsof operation 704 on the vector of accumulated urine volume, rather thanon urine flow rate data as in operation 704. For example, the serverprocessing element 152 sorts the accumulated urine volume data indescending order, and determines the first value in the sorted vector tobe the accumulated urine volume. In another example, the serverprocessing element 152 steps through the accumulated urine volume datausing the buffered value approach as detailed in another example ofoperation 704, and determines that the buffered value at the end of theoperation is the total accumulated volume of urine. In the example ofTable 2, the server processing element 152 would determine theaccumulated void volume as 26.516 mL, occurring at 8 sec.

In operation 710 the server processing element 152 or device processingelement 252 determines average urine flow rate. In one example, theserver processing element 152 removes or ignores data points ofvalidated void data vector that are close or equal to zero. In theexample of Table 2, the server processing element 152 would ignore datapoints 1, 7, and 8. The server processing element 152 then adds a sum ofall the remaining data points of urine flow rate in a validated voiddata vector. The server processing element 152 then counts the number ofremaining data points in the validated void data vector. The serverprocessing element 152 then divides the sum of the urine flow rate databy the number of data points. For example, in Table 2, the serverprocessing element 152 may determine the sum of the remaining datapoints of urine flow rate to be 1+1+2+1.5+1=6.5 mL/sec. The number ofdata points in the urine flow rate vector is five, (e.g., data points2-6, inclusive). The server processing element 152 then determines theaverage flow rate to be 6.5 mL/sec/5=1.3 mL/sec.

In another example, of operation 710 the server processing element 152does not ignore or discard data points of validated void data vectorthat are close or equal to zero, determining an overall average urineflow rate. In the example of Table 2, the sum of all urine flow ratevalues is 6.602 mL/sec. The number of points is eight. The average thenis 6.602 mL/sec/8=0.825 mL/sec.

In operation 712 the server processing element 152 or device processingelement 252 determines the time to maximum urine flow. In one example,the server processing element 152 determines the peak urine flow rateaccording to operation 704. While performing method 700, the serverprocessing element 152 sorts time values associated with urine flow ratevalues while finding the peak urine flow rate. In this example, theserver processing element 152 takes the first value of the sorted timevector and determines it to be the time to peak urine flow rate. Inanother example, the server processing element 152 retrieves thebuffered time value of operation 704 and determines it to be the time topeak urine flow rate. In the example of Table 2, the server processingelement 152 may determine the time to the peak urine flow rate as 4 sec,associated with peak urine flow rate of 2 mL/sec.

In operation 714 the server processing element 152 or device processingelement 252 determines flow time or duration data of the flow event. Inone example, the server processing element 152 determines a firstnon-zero point in the validated void data flow rate vector (e.g., thisis point 2 in Table 2). The server processing element 152 then recordsthe time value associated with the first non-zero flow rate at a firstlocation in memory 154. The server processing element 152 then stepsthrough the data points in the validated void data flow rate vector oneat a time looking for a first zero-valued data point following the firstnon-zero data point. For example, the server processing element 152compares the data points to determine if they have dropped back to zero,or close to zero. If the server processing element 152 determines that adata point is zero or close to zero, the server processing element 152may determine that this data point is the first zero-valued data point.The server processing element 152 then writes the time value associatedwith the first zero-valued data point to a second location in the memory154. Completing the operation, the server processing element 152subtracts the time value in the second memory location from the timevalue in the first memory location to determine a flow time. In anotherexample, the server processing element 152 may apply filtering or otheralgorithms to avoid false positive determinations of either the firstnon-zero flow rate data point, and/or the first zero-valued data pointfollowing the first non-zero flow rate data point. In the example ofTable 2, the first non-zero flow rate data point is point 2, and theassociated time is 2 seconds. The first zero-valued data point followingthe first non-zero flow rate data point is point 7 with an associatedtime of 7 sec. The difference between these associated times, and thusthe flow time, is 7 sec−2 sec=5 sec.

In operation 716 the server processing element 152 or device processingelement 252 determines void time. In one example, the server processingelement 152 reads the last value of time from a validated void data timevector in the memory 254 and determines it to be the void time. In theexample of Table 2, the void time would be 8 sec. In another example,the server processing element 152 reads the value of flow time from thememory 254, such as resulting from operation 714, and adds apredetermined or variable time to the flow time to determine void time.For example, if the flow time resulting from operation 714 is 7 sec, asin Table 2, the server processing element 152 may append a fixed time,e.g., one second to the flow time to determine the void time as 8 sec,or the server processing element 152 determines the last outflow valuetime stamp and determines that to be the end time.

The method may conclude with operation 720, and the server processingelement 152 or device processing element 252 records void profilecharacteristics in a void diary. A void diary may contain informationcollected by the voiding device 200 as well as information collected andrecorded manually by the patient, healthcare providers, insuranceproviders and/or third parties. The void diary may exist in memorystorage on any of the voiding device 200, the user mobile device 108,the server 112, the healthcare provider device 109, the report device110, the third party device 103, or another device. In one example, thevoid diary takes the form of a database, e.g., a relational databasewhere void data as determined by method 700 are stored as fields in avariety of tables. As illustrated in FIG. 11, in another example, thevoid diary shows a summary of data collected about the patient's urinaryhealth, including information collected by the voiding device 200 (e.g.,the number of voids, including a classification by whether they happenedduring the day or night, total and average voided volume, maximumbladder capacity, the size of the smallest void, and a percentage ofurine output during the day and night). Also as illustrated in FIG. 11,the void diary contains information collected by the patient. Forexample, the void diary contains information about the patient's: fluidintake; number of episodes of urinary incontinence (“UI”); sense ofurgency to urinate; activities that preceded or were associated with UI(e.g., laughing, coughing, sneezing, sex, lifting, or running); amountof urine leakage; and absorbent pad use. In another example, the voiddiary provides the ability of a healthcare provider to input data toprovide additional diagnostic and treatment response or performanceinformation to be considered and used in analysis of the diagnosis orefficacy of the treatment. Data input into a voiding device may betransmitted back to the server 112, e.g., from a healthcare providerdevice 109, to the server 112 for recordation, analysis, and reporting.FIG. 20 shows another example of a voiding diary over the course ofthree consecutive days. In the example of a voiding diary illustrated inFIG. 20, the diary includes information such as: total fluid intake;volume voided over a 24 hour period; maximum, average, and minimum voidvolumes; incontinence episodes; leakage; and pad usage split up by dayand night. Alternately, in operation 720, a respective processingelement may create a uroflow study of a single void event, an example ofwhich is illustrated in FIG. 19. The study may include informationrepresentative of the data in FIGS. 6A and 6B, and may include the timeof the void, the patient position (e.g., sitting, standing), the voidedvolume, the voiding time, the flow time, the time to maximum flow, theaverage flow rate, and an overall score for the void event. In oneexample, the study shows an American Urological Association SymptomIndex (“AUA-SI”) score that measures the severity of a patient's overallurological symptoms.

FIG. 8 discloses a method 800 where the processing element on the usermobile device 108 collects void diary data from the server 112 and/orfrom a patient. The method may begin in operation 802 when the patientlaunches an application on user mobile device 108. The application maybe any form of structured computer-executable or interpreted code thatcan be executed by the processing element.

The method may proceed to operation 804 and the processing element,through the application, determines a type of urinary event that hasoccurred such as through an input from the user via an input/outputinterface of the user mobile device 108. A urinary event may be any typeof event relevant to the production or elimination urine. In oneexample, the application asks the patient to choose from among two typesof urinary events: a void or drinking a beverage. In another example,the application asks the patient to choose from among three types ofurinary events: a void, drinking a beverage, or having a leak associatedwith an episode of UI.

The method may then proceed to operation 806 where the processingelement determines if the user has indicated that the urinary event wasa void. In one example, the user mobile device 108 presents a userinterface to the user who then selects an event corresponding to a voidevent. A void is a urinary event in which the user intentionallyeliminates urine from his or her bladder. On the other hand, a leakassociated with UI is where urine is eliminated from the user's bladderin an unintentional, uncontrolled, or unconscious fashion. If the userhas indicated that the event was a void, the method may proceed tooperation 808. If the event was not a void, but rather was an episode ofUI, or fluid intake, the method may proceed to operation 818 or 820 inany order.

In instances where the event is a void, the method may proceed tooperation 808, and the processing element scans the server 112 for voiddata, or requests or retrieves void data from the server 112. In anotherexample, the user mobile device 108 sends a data request to the server112, which then transmits the requested data to the user mobile device108. Alternately, the processing element requests or retrieves relevantvoid data from the voiding device 200. For example, the server 112, orthe user mobile device 108 may connect either directly through wirelessor wired technologies to the voiding device 200, and send a query to thevoiding device 200 to determine if it contains void data. In someexamples, the processing element of the user mobile device 108communicates with the voiding device 200 via Bluetooth®, Wi-Fi®, nearfield communications. In other examples, the processing elementcommunicates with the voiding device 200 on USB or other wiredcommunications methods. In other examples still, the processing elementcommunicates with the voiding device 200 via network 102 using anycombination of wired and wireless technologies.

If the flow event data are available, the method may proceed tooperation 810 and the processing element receives void profilecharacteristics or other void data. In one example, the processingelement receives void profile characteristics from the server 112. Inone example, the processing element receives void profilecharacteristics from the voiding device 200 itself. The processingelement may identify the void profile characteristics to determine if itis the correct data from a recent void, as opposed to old data remainingin memory 254 of the voiding device 200. For example, the processingelement may compare one or more time stamps of the void data to thecurrent time, and determine whether the void data are recent. Theprocessing element may use other methods to identify void data, such asa void data serial number, that may be unique. Processing element mayreceive void profile characteristics by any of the methods ortechnologies previously described with respect to the voiding device200. Concurrently with, or after receiving void data, the processingelement may store the void data in a memory storage 254. The method maythen proceed to operation 812 or 814 in any order.

In operation 812 the application receives user input void data from theuser, e.g., via the user mobile device 108, related to the void event.For example, the application may display a screen to ask about thereasons the patient chose to urinate and provide options or a textualinput which the user can use to input information. In one example, theapplication asks if the patient urinated because of convenience or afeeling of urgency to urinate. If the patient indicates that the voidwas made because of urgency, the operation may proceed and theapplication may ask the patient about the severity of the urgency. Inone example, the application asks the patient to rate the urgency asmild, moderate or severe. The operation may proceed and the applicationasks the patient about any leakage associated with the void event. Inone example, the application asks the patient to rate the amount of UIleakage as: none, drips, wet or soaking. The operation may proceed andthe application asks the patient whether he or she changed leakageprotection as a result of the void. In one example, the application asksthe patient if he or she made no change, changed a panty liner, lightpad, heavy pad, or briefs.

The method may then proceed to operation 814 and the applicationdetermines the diary time slot for the void event. In one example, theapplication asks the patient if he or she is just waking up for the dayand associates void data with awake time if the user answers in theaffirmative. In another example, the application asks the user if he orshe is going to bed for the night, and associates void data with bedtime if the user answers in the affirmative. In another example, theapplication asks the user if he or she got up during the night due to asense of urgency to urinate.

The method may then proceed to operation 816 where the processingelement associates diary data with a user's void diary. The processingelement may upload diary data to a void diary stored in memory on any ofthe voiding device 200, the user mobile device 108, the sever 112, thehealthcare provider device 109, the third party device 103, or evenanother device. The processing element may perform this upload using anycombination of the communications methods and technologies previouslydisclosed for connecting these devices. Further, the processing elementassociates the collected diary data from both the user and the voidingdevice 200 with a specific diary associated with that user. Theprocessing element may display a void diary or void data on any of thevoiding device 200, the user mobile device 108, the sever 112, thehealthcare provider device 109, the third party device 103, or evenanother device.

If in operation 806, the event was determined not to be a void event,the method may proceed to operation 818, if in operation 806 the userindicated that the urinary event was not a void, but rather was anepisode of UI, or fluid intake.

The method may proceed to operation 818 and the processing element viathe application receives information regarding the user's fluid intake.In one example, the application presents the user with a series ofgraphical representations of beverages of various sizes (e.g., a cup(small), a can (medium), or a bottle (large)). The application may askthe user to input the volume of fluid he or she drank. In one example,the application asks the user to input the number of fluid ounces he orshe drank.

The method may optionally proceed to operation 820, and the processingelement via the application asks the user about UI leakage. In variousexamples, the application asks the user about his or her: number ofepisodes of UI; sense of urgency to urinate; activities that preceded orwere associated with UI (e.g., laughing, coughing, sneezing, sex,lifting, or running); amount of urine leakage; and absorbent pad use orchanges.

FIGS. 16A-16E are flow diagrams illustrating a specific implementationof the method of FIG. 8. FIGS. 16A-16E are examples of a specificimplementation, and are not intended to limit method 800 in any way. Asillustrated in FIG. 16A, the user mobile device 108 executes anapplication that starts with a splash screen welcoming the user. Theapplication then proceeds to a screen to ask the user about certainurinary events, such as beverage consumption, controlled void events,and UI events, or leaks. If the user selects “I had a beverage” theapplication proceeds to ask about the size of the beverage. FIG. 16Eillustrates sample graphics of the user interface related to beverageconsumption. If the user selects, “I went to the bathroom”, theapplication attempts to scan the server 112 for validated void data. Ifvalidated void data are found, the application proceeds to node B in asillustrated in FIG. 16C and the application asks the user about thereasons he or she urinated, e.g., the level of urgency, convenience, thelevel of UI leakage, and any change in leakage protection. Theapplication also asks the user about whether he or she is getting up forthe day, or went to the bathroom during the night due to urgency, asillustrated in node A in FIG. 16A. If the user selects, “I had a leak”,the application proceeds to node D, FIG. 16D where the user is askedabout activity associated with the leak; e.g., running, lifting,laughing, sex, etc.; the size of the leak; and leakage protectionchanges. The application may also show help screens as illustrated inFIG. 16B.

As mentioned, the voiding device 200 and void data can be used tocollect and analyze urinary data for treatment. FIG. 9 discloses amethod 900 to analyze data regarding the patient's urinary healthutilizing the voiding device 200. The method may be executed in one ormore of the healthcare provider device 109, the report device 110, theserver 112, the third party device 103, the user mobile device 108, oreven another suitable device.

The method may begin with operation 902 and a processing elementreceives patient data from one or more of the voiding device 200, theserver 112, the healthcare provider device 109, the report device 110,or a third party device 103. The processing element may in the voidingdevice 200, the report device 110, the healthcare provider device 109,the third party device 103, the server 112, or another device. Therespective processing element may receive patient data via network 102from another device, or it may receive patient data from manual inputduring or following an examination or interview of the patient. In oneexample, a doctor or other healthcare provider manually inputs patientinformation into the healthcare provider device 109 such as a computer,tablet, mobile phone or other computing device. The patient data caninclude height, weight, age, name, or other patient identifier, or thelike data corresponding to the patient. The type of patient data mayvary as desired but generally is to identify a patient out of aplurality of patients.

The method may proceed to operation 904 and a healthcare providerassigns a voiding device 200 for patient use, and associates, or createsa linkage between, a particular voiding device 200 and a particularpatient. The voiding device 200 may have a device identifier that may beunique. Optionally, different portions of the voiding devices 200 mayhave different device identifiers, e.g., the handle 202 may have onedevice identifier and the flow chamber 204 may have another deviceidentifier. The device identifiers may associate a handle 202 with aflow chamber 204, and with a patient. In one example, a unique deviceidentifier is a serial number, bar code, image, etc., such that thevoiding device 200 can be tracked as to which patient it is associatedwith, and may be dissociated from one patient and associated withanother patient. In one example, the device identifier may be associatedwith a disposable flow chamber 204 that is removable attached to thehandle 202. A new disposable flow chamber 204 may be associated with thehandle 202 for each patient using the voiding device 200. The flowchamber 204 may contain an RFID element that stores the deviceidentifier. The device identifier stored in the RFID element may be readto ensure the flow chamber 204 is used with only one patient.

Patients may also have patient identifiers that may be unique. In oneexample, a unique patient identifier is a patient number, or patientname plus birthdate. In one example, to associate the voiding device 200with a patient, the healthcare provider causes the processing elementwithin the healthcare provider device 109 to create a record in memorylinking a patient unique identifier with the voiding device 200 uniqueidentifier. This record may be transmitted to the server 112, or otherdevices within the information management system 100. In anotherexample, the respective processing element causes a confirmation displayconfirming a linkage between the patient identifier and the deviceidentifier.

The method may proceed to operation 906 and a void diary is activated orassociated with a particular patient. In one example, the healthcareprovider device 109 associates a voiding devices 200 with a patient. Inone example, the void diary is a database stored in memory on thehealthcare provider device 109, the user mobile device 108, and/or onthe server 112 and contains records regarding the patient's urinaryhealth. The void diary contains a record of the association between thepatient and the voiding device 200, such as that resulting fromoperation 904.

The method may proceed to operation 908 and the respective processingelement receives void diary data corresponding to the user's voiding orurinary events, such as the inputs from the method 800 in FIG. 8. Therespective processing element may receive diary data via the network 102from one or more of the voiding device 200, the report device 110, thehealthcare provider device 109, the third party device 103, the server112, or another device. Alternately, the respective processing elementmay receive void diary data directly from one of the preceding devices.In one example, the healthcare provider device 109 is a tablet, or otherportable computer in communication with the user mobile device 108 overthe network 102. The user mobile device 108, such as a smart phone, maybe in communication with both the healthcare provider device 109 and thevoiding device 200. In one example, the user mobile device 108 transmitsvoid diary data to the healthcare provider device 109 over a Wi-Fi®network connection. In another example, the voiding device 200 transmitsvoid diary data over a private cellular network. In one example, theuser mobile device 108 sends void diary data to the server 112 that isin communication with the healthcare provider device 109, which receivesvoid diary data from the server 112.

As illustrated in FIG. 8, the void diary data corresponds to the urinaryand void events as well as patient input information such as patientfeelings, consumption, etc. The method may proceed to operation 910 andthe respective processing element may select a particular void diary toaccess. In one example, the respective processing element displays auser interface on a tablet computer and a doctor, after providingsecurity authentication, selects a diary from among various void diariesavailable to access. In one example, the respective processing elementsends an alert to the doctor telling him/her that new void diaryinformation is available, and provides a link, such as a hyperlink, forthe doctor to follow, allowing access to the void diary.

The method may proceed to operation 912 and the respective processingelement outputs void diary data or urinary health report containinginformation gathered by the voiding device 200 and/or informationgathered by the patient, that relate to the patient's urinary health.FIG. 11 illustrates one example of a void diary report. The void diaryreport may be displayable on a user mobile device 108, healthcareprovider device 109, or other device. In this example, void data areseen for three days and nights, for a patient. Void data presented inthe example include: daily data for the number of voids; void volume;fluid intake; a count of UI episodes; daily averages for urine output,fluid intake, maximum bladder capacity, number of voids, average voidvolume, minimum void volume, daily and nightly UI episode count. Theexample also shows data on UI episodes such as urgency of urination,activities leading to UI episodes, the amount of urine leakage, andabsorbent pad use. The void diary includes user input such as receivedby a user from the input/output of a user mobile device 108, inputreceived from the healthcare provider device 109, as well as void datacollected from a voiding device 200. For example, the diary in FIG. 11contains user feelings, such as urgency of urination, as well as voiddata from voiding device 200, such as voided volume, number of voids,and maximum bladder capacity.

The method may proceed to operation 914 and the respective processingelement waits for the prescribed time for a patient to use the voidingdevice 200 and/or to keep a void diary. During this operation,additional void diary data may be accumulated and the method may returnto any of operations 902-910, as desired.

The method may proceed to operation 916 and the respective processingelement allows a healthcare provider or other person to dissociate thevoiding device 200 with a particular patient, breaking, destroying, ordeactivating the association made between patient and the voiding device200 in operation 904. A server 112 may keep a record of the patients whohave used a particular voiding device 200, and/or the voiding devices200 associated with a particular patient after the association isdeactivated. The dissociation may also trigger a report to be generatedby a processing element in one or more devices. The voiding device 200may then be returned in whole or in part to the healthcare provider. Thehealthcare provider, or a medical device service provider, cleans,sanitizes, and recharges the device for further use with anotherpatient. The healthcare provider may separate portions of the deviceusing a custom tool or key, (as illustrated for example in FIGS. 2O and2P) discard part of the device, saving a durable portion for reuse. Inone example, the healthcare provider discards the flow chamber 204,keeping the handle 202 of the voiding device 200 for further use. In oneexample, the device identifier is read from the RFID element within theflow chamber 204 to ensure that particular device identifier is nolonger associated with the patient, and may not be re-assigned to anynew patient, ensuring single patient use of the flow chamber 204. Theflow chamber 204 is separated from the handle 202, and discarded. A newflow chamber 204 with a new device identifier may be associated with thehandle 202. The new device identifier may be stored in an RFID elementwithin the flow chamber 204. The method may end in operation 920.

FIGS. 17A-17E are flow diagrams illustrating a specific implementationof the method of FIG. 9, as may be implemented in an application on atablet or other computer. FIGS. 17A-17E are examples of a specificimplementation, and are not intended to limit method 900 in any way. Asillustrated in FIG. 17A, the application begins with a splash screenthen proceeds to node A where it offers the user the options to start anew study of a patient, view reports of an existing study, return adevice and dissociate it with a patient, or access a settings menu. Theapplication contains provisions for a user to authenticate himself orherself. Node B of FIG. 17A illustrates various screens in theapplication allowing the user to input information related to a newstudy, including patient information, the type of study to be completed,whether the patient has a smart phone. As illustrated in FIG. 17B, thescreens proceed to allow the user to associate a flow chamber 204 with ahandle 202, and scan the assembled device, and associate the assembledvoiding device 200 with the patient. If the association of voidingdevice 200 to patient is successful, the application proceeds to FIG.17C, node B8 to complete the setup of the new study. If the user choosesto view reports from the opening screen, the application proceeds toFIG. 17D, node C, and then FIG. 17 E, node C1 where the userauthenticates him or herself and may then view void diary reports onpatients. Is the user chooses to return a device from the openingscreen, the application proceeds to FIG. 17D, node D and FIG. 17E, nodeDl. Here the user is prompted to scan the device to return, and isnotified when the scan is successful. If the user chooses to enter thesettings screen from the opening screen, he or she may enter a settingsscreen as illustrated for example in FIG. 17D.

FIG. 10 discloses a method 1000 where a processing element receivespre-treatment void diary information and post-treatment void diaryinformation in order to assess efficacy of and payments for thetreatment. The processing element may in the voiding device 200, thereport device 110, the healthcare provider device 109, the third partydevice 103, the server 112, or another device. The ability to compareinformation may help the healthcare provider choose the best course oftreatment, and may also establish a baseline of symptoms that an insurerand/healthcare provider can use to assess the efficacy of the treatment.Examples of reports generated by the disclosed systems are illustratedin FIGS. 21 and 22, showing a patient's uroflow study and void diaryinformation over the span of several months.

The method may begin in operation 1002 where pre-treatment void diaryinformation is be received by the respective processing element onreport device 110 or on the healthcare provider device 109. Void diaryinformation may be collected in the manner and with the methods anddevices described above. In one example, a healthcare providerprescribes a voiding device 200 to a patient seeking care for UIsymptoms and asks the patient to use the voiding device 200 and keep avoid diary before any treatment begins. The patient then collects voiddiary information as disclosed. The server 112 may make reports or thevoid diary available to the report device 110 and/or the healthcareprovider device 109. In one example, the server may provide a link tothe reports or void diary. In another example, the server 112 maytransmit a copy of the report or void diary. In one example, apre-treatment void diary 2200 is illustrated in FIG. 22. Alternately, apre-treatment uroflow study 2100, illustrated for example, in FIG. 21,may be received.

The method may proceed to operation 1004 and the patient is treated forUI symptoms and/or causes and collects post-treatment void diaryinformation that is received by the respective processing element. Inone example, the patient collects void diary information using thevoiding device 200 and the user mobile device 108. The patient transmitsthe post-treatment void diary information to the server 112, thehealthcare provider device 109, the report device 110 or other devicesaccording to the methods disclosed. For example, the patient may use thevoiding device 200 as disclosed, and the voiding device 200 may transmitvoid diary information to the server 112, the healthcare provider device109, the report device 110 or other devices. In various examples, asillustrated in FIGS. 21 and 22, post treatment uroflow studies 2102,2104 and post-treatment void diaries, 2202, 2204 may be generated.

The method may proceed to operation 1006 and the respective processingelement analyzes the pre-treatment and post-treatment void diariesand/or uroflow studies to provide comparison information to determinetreatment effectiveness. In one example, the respective processingelement produces a report, for example, FIG. 2I or 22 showing the changein the number of UI episodes, a change in leakage volumes, urgency,urine volume, urine flow rates, and other data for the post-treatmentcondition, allowing healthcare providers and insurers to make decisionson treatment effectiveness.

The method may proceed to operation 1008 and the respective processingelement ranks effectiveness for different treatments based onimprovements in post-treatment UI symptoms. In one example, therespective processing element aggregates anonymized patient dataincluding post-treatment outcomes. The respective processing elementfurther categorizes outcomes according to patient demographic data, suchas weight, age, gender, ethnicity, and further categorizes dataaccording to the treatments employed. The respective processing elementmay then rank the most effective treatments for the whole population ofpatient records, or may a provide rankings for subsets of thepopulation. For example, the respective processing element may determinethat treatment with drug “A” is the most effective for females over theage of 50, whereas it may determine that treatment with drug “B” is mosteffective for males over the age of 50. The method ends in operation1010

FIG. 15 illustrates an example of a typical usage method 1500 for thevoiding device 200. The method may begin in operation 1502 when apatient picks up the voiding device 200. In operation 1504 the voidingdevice 200 senses motion for instance by way of the validation sensor260, or the patient's grip by way of the power button 279 and/or a touchsensor. In operation 1504, the voiding device 200 begins recordingsensor data, such as validation sensor 260 data, fluid level data,and/or temperature, conductivity, opacity, or other data. In operation1506, the patient voids through the voiding device 200. In operation1508, the patient sets the voiding device 200 down. In operation 1510the voiding device 200 stops recording sensor data. In operation 1512,the voiding device 200 communicates with, and sends flow event data to,the server 112. In operation 1514, the server 112 validates the flowdata as either being validated void data, or discards it as not beingvalidated void data.

The above specifications, examples, and data provide a completedescription of the structure and use of exemplary examples of theinvention as defined in the claims. Although various examples of thedisclosure have been described above with a certain degree ofparticularity, or with reference to one or more individual examples,those skilled in the art could make numerous alterations to thedisclosed examples without departing from the spirit or scope of theclaimed invention. Other examples are therefore contemplated. It isintended that all matter contained in the above description and shown inthe accompanying drawings shall be interpreted as only illustrative ofparticular examples and not limiting. Changes in detail or structure maybe made without departing from the basic elements of the invention asdefined in the following claims.

All relative and directional references (including: upper, lower,upward, downward, left, right, leftward, rightward, top, bottom, side,above, below, front, middle, back, vertical, horizontal, right side up,upside down, sideways, and so forth) are given by way of example to aidthe reader's understanding of the particular examples described herein.They should not be read to be requirements or limitations, particularlyas to the position, orientation, or use unless specifically set forth inthe claims. Connection references (e.g., attached, coupled, connected,joined, and the like) are to be construed broadly and may includeintermediate members between a connection of elements and relativemovement between elements. As such, connection references do notnecessarily infer that two elements are directly connected and in fixedrelation to each other, unless specifically set forth in the claims.

1. A method for generating a urine flow void profile for a user flowevent, comprising: receiving by a processing element a plurality ofoutputs from a fluid level sensor corresponding to a plurality of levelsof fluid flowing through a voiding device during a flow event;determining by the processing element a beginning and an end time of thefluid flow into the voiding device during the flow event; analyzing theplurality of outputs of the fluid level sensor over a time intervaldefined by the beginning and end time of the fluid flow to determine atleast one of a fluid flow rate data and an accumulated volume data forthe fluid flowing through the voiding device; and storing the fluid flowrate data and the accumulated flow volume data in a memory.
 2. Themethod of claim 1, wherein the plurality of outputs of the fluid levelsensor correspond to two or more positions of the fluid level sensorduring the time interval.
 3. The method of claim 2, wherein the fluidlevel sensor comprises: a float; a magnet; and a displacement sensor incommunication with the magnet to detect variations in position of themagnet.
 4. The method of claim 3, wherein the displacement sensor is aHall effect sensor.
 5. The method of claim 1, further comprising:analyzing by the processing element one or more validationcharacteristics detected by the voiding device during the flow event tovalidate the flow event as a void event.
 6. The method of claim 5,wherein the one or more validation characteristics comprise one or more:acceleration of the voiding device during the flow event; orientation ofthe voiding device during the flow event; presence of a user hand on thevoiding device during the flow event; temperature of the fluid flowingthrough the voiding device during the flow event; or total volume of thefluid flowing through the voiding device during the flow event.
 7. Themethod of claim 1, wherein the accumulated flow volume data aredetermined by numerical integration of the fluid flow rate data andwherein the fluid flow rate data are determined based on a predeterminedcharacteristic of the voiding device represented by a lookup table. 8.The method of claim 1, wherein the determining of the fluid flow ratefurther comprises: receiving from an validation sensor a plurality oforientation values for the voiding device over the time interval, theorientation values including a pitch value; translating the orientationvalues and the plurality of outputs of the fluid level sensor during thetime interval to a fluid flow rate based on a predeterminedcharacteristic of the voiding device.
 9. The method of claim 1, furthercomprising: receiving by the processing element an initial position ofthe fluid level sensor; and receiving by the processing element a timestamp.
 10. The method of claim 1, further comprising: receiving by theprocessing element an initial orientation of the voiding device inspace; and receiving by the processing element a time stamp.
 11. Themethod of claim 8, wherein the predetermined characteristic of thevoiding device is represented by a lookup table.
 12. The method of claim11, wherein the determining of the fluid flow rate further comprises:receiving from the validation sensor a plurality of orientation valuesfor the voiding device over the time interval, the orientation valuesincluding a roll value; determining the fluid flow rate by comparing twoor more of the plurality of pitch values, plurality of the roll values,or plurality of outputs of the fluid level sensor, to a lookup table.13. A method for validating a flow event detected by a voiding device ascorresponding to a urinary event, comprising: receiving from a fluidsensor and a validation sensor flow characteristics of a fluid flowthrough the voiding device during the flow event; determining that theflow event corresponds to a urinary event; for the urinary eventtransmitting unanalyzed data to a server; and outputting a void profilecorresponding to the flow event.
 14. The method of claim 13, whereinanalyzing one or more detected characteristics comprises at least oneof: comparing a detected orientation of the fluid sensor to a urinaryevent position to determine that the detected orientation is valid;comparing a detected fluid flow rate to a characteristic urinary eventflow rate to determine that the detected flow rate is valid; comparing adetected temperature to a characteristic urinary temperature todetermine that the detected temperature is valid.
 15. The method ofclaim 13, further comprising: receiving from the validation sensor anorientation value for the voiding device; and determining that the flowevent corresponds to a urinary event based on the orientation value. 16.A system for assessing the urinary health of a patient, comprising: ahandheld voiding device comprising: a flow sensor; a device processingelement; and a flow chamber wherein the handheld voiding device receivespatient urine and receives by the device processing element a pluralityof outputs of the flow sensor corresponding to a plurality of levels ofa fluid flowing through the handheld voiding device during a flow event;a server in communication with the handheld voiding device, wherein theserver receives flow event data from the voiding device and by a serverprocessing element analyzes the flow event data to validate a voidevent, and determines a parameter associated with the valid void event,and associates the parameter with a void diary stored in a memory, andoutputs a urinary health report; and a healthcare provider device incommunication with the server, wherein the healthcare provider devicereceives the urinary health report from the server.
 17. The system ofclaim 16, further comprising a charging station in communication with aninterface of the voiding device.
 18. The system of claim 17, wherein thedevice processing element receives firmware via the interface.
 19. Thesystem of claim 17, wherein the device processing element determines astatus of the handheld voiding device; receives information from thecharging station via the interface; and indicates readiness forcontinued use through an indicator.
 20. The system of claim 16, whereinthe handheld voiding device further comprises: a GPS assembly incommunication with the device processing element, and the deviceprocessing element determines a relative position of the voiding device.21-27. (canceled)